DOE Office of Scientific and Technical Information (OSTI.GOV)

Napper, P.R.; Carpenter, W.R.; Garner, R.W.

By DOE-ID Order 5481.1A, a five year currency review is required of the Safety Analysis Reports of all ID or ID contractor operations having hazards of a type and magnitude not routinely encountered and/or accepted by the public. In keeping with this order, a currency review has been performed of the Advanced Test Reactor Critical Facility (ADTRC) Safety Analysis Report (SAR), Issue 003, 1990. The objectives of this currency review were to: evaluate the content, completeness, clarity of presentation and compliance with NRC Regulatory Guides and DOE Orders, etc., and evaluate the technical content of the SAR, particularly the Technicalmore » Specifications, and to evaluate the safety of continued operation of the ATRC. The reviewers concluded that although improvements may be needed in the overall content, clarity, and demonstration of compliance with current orders and regulations, the safety of the ATRC is in no way compromised and no unreviewed safety questions were identified. 6 figs., 3 tabs.« less

Risk analysis based CWR track buckling safety evaluations

DOT National Transportation Integrated Search

1999-12-01

As part of the Federal Railroad Administration's (FRA) track systems research program, the US DOT'S Volpe Center is conducting analytic and experimental investigations to evaluate track lateral strength and stability limits for improved safety and pe...

Safety and capacity evaluation for interstates in Kentucky.

DOT National Transportation Integrated Search

2005-04-01

This analysis and evaluation was directed toward assessing safety and capacity issues on interstates in Kentucky and, particularly, the manner in which commercial vehicle traffic affects these issues. Analyses was undertaken to show past trends and p...

Accident analysis and control options in support of the sludge water system safety analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

HEY, B.E.

A hazards analysis was initiated for the SWS in July 2001 (SNF-8626, K Basin Sludge and Water System Preliminary Hazard Analysis) and updated in December 2001 (SNF-10020 Rev. 0, Hazard Evaluation for KE Sludge and Water System - Project A16) based on conceptual design information for the Sludge Retrieval System (SRS) and 60% design information for the cask and container. SNF-10020 was again revised in September 2002 to incorporate new hazards identified from final design information and from a What-if/Checklist evaluation of operational steps. The process hazards, controls, and qualitative consequence and frequency estimates taken from these efforts have beenmore » incorporated into Revision 5 of HNF-3960, K Basins Hazards Analysis. The hazards identification process documented in the above referenced reports utilized standard industrial safety techniques (AIChE 1992, Guidelines for Hazard Evaluation Procedures) to systematically guide several interdisciplinary teams through the system using a pre-established set of process parameters (e.g., flow, temperature, pressure) and guide words (e.g., high, low, more, less). The teams generally included representation from the U.S. Department of Energy (DOE), K Basins Nuclear Safety, T Plant Nuclear Safety, K Basin Industrial Safety, fire protection, project engineering, operations, and facility engineering.« less

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

PubMed

Crowe, Brenda J; Xia, H Amy; Berlin, Jesse A; Watson, Douglas J; Shi, Hongliang; Lin, Stephen L; Kuebler, Juergen; Schriver, Robert C; Santanello, Nancy C; Rochester, George; Porter, Jane B; Oster, Manfred; Mehrotra, Devan V; Li, Zhengqing; King, Eileen C; Harpur, Ernest S; Hall, David B

2009-10-01

The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period. SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions. An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission. We recognize that there may be other valid approaches. The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond.

Safety climate and attitude as evaluation measures of organizational safety.

PubMed

Isla Díaz, R; Díaz Cabrera, D

1997-09-01

The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

Automated Pedestrian Detection, Count and Analysis System

DOT National Transportation Integrated Search

2015-04-15

Pedestrian and bicycle count data is necessary for transportation planning, implementing safety countermeasures, and traffic management. This data is critical when evaluating the pedestrian level of service of safety (LOSS) and pedestrian safety perf...

Loss of Coolant Accident (LOCA) / Emergency Core Coolant System (ECCS Evaluation of Risk-Informed Margins Management Strategies for a Representative Pressurized Water Reactor (PWR)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Szilard, Ronaldo Henriques

A Risk Informed Safety Margin Characterization (RISMC) toolkit and methodology are proposed for investigating nuclear power plant core, fuels design and safety analysis, including postulated Loss-of-Coolant Accident (LOCA) analysis. This toolkit, under an integrated evaluation model framework, is name LOCA toolkit for the US (LOTUS). This demonstration includes coupled analysis of core design, fuel design, thermal hydraulics and systems analysis, using advanced risk analysis tools and methods to investigate a wide range of results.

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

RPP-PRT-58489, Revision 1, One Systems Consistent Safety Analysis Methodologies Report. 24590-WTP-RPT-MGT-15-014

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gupta, Mukesh; Niemi, Belinda; Paik, Ingle

2015-09-02

In 2012, One System Nuclear Safety performed a comparison of the safety bases for the Tank Farms Operations Contractor (TOC) and Hanford Tank Waste Treatment and Immobilization Plant (WTP) (RPP-RPT-53222 / 24590-WTP-RPT-MGT-12-018, “One System Report of Comparative Evaluation of Safety Bases for Hanford Waste Treatment and Immobilization Plant Project and Tank Operations Contract”), and identified 25 recommendations that required further evaluation for consensus disposition. This report documents ten NSSC approved consistent methodologies and guides and the results of the additional evaluation process using a new set of evaluation criteria developed for the evaluation of the new methodologies.

The Evaluation of the Safety Benefits of Combined Passive and On-Board Active Safety Applications

PubMed Central

Page, Yves; Cuny, Sophie; Zangmeister, Tobias; Kreiss, Jens-Peter; Hermitte, Thierry

2009-01-01

One of the objectives of the European TRACE project (TRaffic Accident Causation in Europe, 2006–2008) was to estimate the proportion of injury accidents that could be avoided and/or the proportion of injury accidents where the severity could be mitigated for on-the-market safety applications, if 100 % of the car fleet would be equipped with them. We have selected for evaluation the Electronic Stability Control (ESC) and the Emergency Brake Assist (EBA) applications. As for passive safety systems, recent cars are designed to offer overall safety protection. Car structure, load limiters, front airbags, side airbags, knee airbags, pretensioners, padding and non aggressive structures in the door panel, the dashboard, the windshield, the seats, and the head rest also contribute to applying more protection. The whole safety package is very difficult to evaluate separately, one element independently segmented from the others. We decided to consider evaluating the effectivenessof the whole passive safety package, This package,, for the sake of simplicity, was the number of stars awarded at the Euro NCAP testing. The challenges were to compare the effectiveness of some safety configuration SC I, with the effectiveness of a different safety configuration SC II. A safety configuration is understood as a package of safety functions. Ten comparisons have been carried out such as the evaluation of the safety benefit of a fifth star given that the car has four stars and an EBA. The main outcome of this analysis is that any addition of a passive or active safety function selected in this analysis is producing increased safety benefits. For example, if all cars were five stars fitted with EBA and ESC, instead of four stars without ESC and EBA, injury accidents would be reduced by 47.2% for severe injuries and 69.5% for fatal injuries. PMID:20184838

Regulatory assessment with regulatory flexibility analysis and paperwork reduction act analysis : draft regulatory evaluation : Notice of Proposed Rulemaking -- Pipeline Safety : Polyamide-11 (PA-11) plastic pipe design pressures

DOT National Transportation Integrated Search

2007-06-01

The Pipeline and Hazardous Materials Safety Administration (PHMSA) is proposing changes to the Federal pipeline safety regulations in 49 CFR Part 192, which cover the transportation of natural gas by pipeline. Specifically, PHMSA is proposing to chan...

Analysis of safety impacts of access management alternatives using the surrogate safety assessment model : final report.

DOT National Transportation Integrated Search

2017-06-01

The purpose of this study was to evaluate if the Surrogate Safety Assessment Model (SSAM) could be used to assess the safety of a highway segment or an intersection in terms of the number and type of conflicts and to compare the safety effects of mul...

Selected considerations of implementation of the GNSS

NASA Astrophysics Data System (ADS)

Cwiklak, Janusz; Fellner, Andrzej; Fellner, Radoslaw; Jafernik, Henryk; Sledzinski, Janusz

2014-05-01

The article describes analysis of the safety and risk for the implementation of precise approach procedures (Localizer Performance and Vertical Guidance - LPV) with GNSS sensor at airports in Warsaw and Katowice. There were used some techniques of the identification of threats (inducing controlled flight into terrain, landing accident, mid-air collision) and evaluations methods based on Fault Tree Analysis, probability of the risk, safety risk evaluation matrix and Functional Hazard Assesment. Also safety goals were determined. Research led to determine probabilities of appearing of threats, as well as allow compare them with regard to the ILS. As a result of conducting the Preliminary System Safety Assessment (PSSA), there were defined requirements essential to reach the required level of the safety. It is worth to underline, that quantitative requirements were defined using FTA.

Multilevel models in the explanation of the relationship between safety climate and safe behavior.

PubMed

Cheyne, Alistair; Tomás, José M; Oliver, Amparo

2013-01-01

This study examines the relationships between components of organizational safety climate, including employee attitudes to organizational safety issues; perceptions of the physical working environment, and evaluations of worker engagement with safety issues; and relates these to self-reported levels of safety behavior. It attempts to explore the relationships between these variables in 1189 workers across 78 work groups in a large transportation organization. Evaluations of safety climate, the working environment and worker engagement, as well as safe behaviors, were collected using a self report questionnaire. The multilevel analysis showed that both levels of evaluation (the work group and the individual), and some cross-level interactions, were significant in explaining safe behaviors. Analyses revealed that a number of variables, at both levels, were associated with worker engagement and safe behaviors. The results suggest that, while individual evaluations of safety issues are important, there is also a role for the fostering of collective safety climates in encouraging safe behaviors and therefore reducing accidents.

Safety evaluation of joint and conventional lane merge configurations for freeway work zones.

PubMed

Ishak, Sherif; Qi, Yan; Rayaprolu, Pradeep

2012-01-01

Inefficient operation of traffic in work zone areas not only leads to an increase in travel time delays, queue length, and fuel consumption but also increases the number of forced merges and roadway accidents. This study evaluated the safety performance of work zones with a conventional lane merge (CLM) configuration in Louisiana. Analysis of variance (ANOVA) was used to compare the crash rates for accidents involving fatalities, injuries, and property damage only (PDO) in each of the following 4 areas: (1) advance warning area, (2) transition area, (3) work area, and (4) termination area. The analysis showed that the advance warning area had higher fatality, injury, and PDO crash rates when compared to the transition area, work area, and termination area. This finding confirmed the need to make improvements in the advance warning area where merging maneuvers take place. Therefore, a new lane merge configuration, called joint lane merge (JLM), was proposed and its safety performance was examined and compared to the conventional lane merge configuration using a microscopic simulation model (VISSIM), which was calibrated with real-world data from an existing work zone on I-55 and used to simulate a total of 25 different scenarios with different levels of demand and traffic composition. Safety performance was evaluated using 2 surrogate measures: uncomfortable decelerations and speed variance. Statistical analysis was conducted to determine whether the differences in safety performance between both configurations were significant. The safety analysis indicated that JLM outperformed CLM in most cases with low to moderate flow rates and that the percentage of trucks did not have a significant impact on the safety performance of either configuration. Though the safety analysis did not clearly indicate which lane merge configuration is safer for the overall work zone area, it was able to identify the possibly associated safety changes within the work zone area under different traffic conditions. Copyright © 2012 Taylor & Francis Group, LLC

Report on SARS backfit evaluation, Catalytic, Inc. Solvent Refined Coal Pilot Plant, Wilsonville, Alabama

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meyer, A.F. Jr.

1980-07-02

A site visit was made in company with the DOE-OPTA-EA Safety and Health Official for the purpose of providing that official with technical assistance in evaluating the validity of an earlier DOE-OPTA recommendation exempting this facility from the Safety and Analysis and Review backfit requirements of DOE Order 5481.1. A further purpose of the visit was to assess and evaluate the occupational safety and health program at this facility, as compared with the criteria and guidelines contained in ASFE Order 5481.1. Adequate documentation regarding compliance with codes, standards, and regulations were observed at this facility. There is in existence anmore » ongoing continuous safety analysis effort for both modifications or additions to this facility. Adequate environmental safeguards and plans and procedures were observed. The SARS backfit exemption is appropriate. The occupational safety and health program is in many ways a model for the scope of work and nature of hazards involved, and is consistent with ASFE guidelines and statutory requirements.« less

Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists

PubMed Central

Fois, Romano A.; McLachlan, Andrew J.; Chen, Timothy F.

2017-01-01

Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns’ patient safety attitudes. However, other factors likely influenced their attitudes in the longer term. PMID:28289295

Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists.

PubMed

Walpola, Ramesh L; Fois, Romano A; McLachlan, Andrew J; Chen, Timothy F

2017-02-25

Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns' patient safety attitudes. However, other factors likely influenced their attitudes in the longer term.

Analysis of existing work-zone devices with MASH safety performance criteria.

DOT National Transportation Integrated Search

2009-02-01

Crashworthy, work-zone, portable sign support systems accepted under NCHRP Report No. 350 were analyzed to : predict their safety peformance according to the TL-3 MASH evaluation criteria. An analysis was conducted to determine : which hardware param...

Applying importance-performance analysis to patient safety culture.

PubMed

Lee, Yii-Ching; Wu, Hsin-Hung; Hsieh, Wan-Lin; Weng, Shao-Jen; Hsieh, Liang-Po; Huang, Chih-Hsuan

2015-01-01

The Sexton et al.'s (2006) safety attitudes questionnaire (SAQ) has been widely used to assess staff's attitudes towards patient safety in healthcare organizations. However, to date there have been few studies that discuss the perceptions of patient safety both from hospital staff and upper management. The purpose of this paper is to improve and to develop better strategies regarding patient safety in healthcare organizations. The Chinese version of SAQ based on the Taiwan Joint Commission on Hospital Accreditation is used to evaluate the perceptions of hospital staff. The current study then lies in applying importance-performance analysis technique to identify the major strengths and weaknesses of the safety culture. The results show that teamwork climate, safety climate, job satisfaction, stress recognition and working conditions are major strengths and should be maintained in order to provide a better patient safety culture. On the contrary, perceptions of management and hospital handoffs and transitions are important weaknesses and should be improved immediately. Research limitations/implications - The research is restricted in generalizability. The assessment of hospital staff in patient safety culture is physicians and registered nurses. It would be interesting to further evaluate other staff's (e.g. technicians, pharmacists and others) opinions regarding patient safety culture in the hospital. Few studies have clearly evaluated the perceptions of healthcare organization management regarding patient safety culture. Healthcare managers enable to take more effective actions to improve the level of patient safety by investigating key characteristics (either strengths or weaknesses) that healthcare organizations should focus on.

Incorporating organisational safety culture within ergonomics practice.

PubMed

Bentley, Tim; Tappin, David

2010-10-01

This paper conceptualises organisational safety culture and considers its relevance to ergonomics practice. Issues discussed in the paper include the modest contribution that ergonomists and ergonomics as a discipline have made to this burgeoning field of study and the significance of safety culture to a systems approach. The relevance of safety culture to ergonomics work with regard to the analysis, design, implementation and evaluation process, and implications for participatory ergonomics approaches, are also discussed. A potential user-friendly, qualitative approach to assessing safety culture as part of ergonomics work is presented, based on a recently published conceptual framework that recognises the dynamic and multi-dimensional nature of safety culture. The paper concludes by considering the use of such an approach, where an understanding of different aspects of safety culture within an organisation is seen as important to the success of ergonomics projects. STATEMENT OF RELEVANCE: The relevance of safety culture to ergonomics practice is a key focus of this paper, including its relationship with the systems approach, participatory ergonomics and the ergonomics analysis, design, implementation and evaluation process. An approach to assessing safety culture as part of ergonomics work is presented.

Analysis of School Food Safety Programs Based on HACCP Principles

ERIC Educational Resources Information Center

Roberts, Kevin R.; Sauer, Kevin; Sneed, Jeannie; Kwon, Junehee; Olds, David; Cole, Kerri; Shanklin, Carol

2014-01-01

Purpose/Objectives: The purpose of this study was to determine how school districts have implemented food safety programs based on HACCP principles. Specific objectives included: (1) Evaluate how schools are implementing components of food safety programs; and (2) Determine foodservice employees food-handling practices related to food safety.…

CRITICALITY SAFETY CONTROLS AND THE SAFETY BASIS AT PFP

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kessler, S

2009-04-21

With the implementation of DOE Order 420.1B, Facility Safety, and DOE-STD-3007-2007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities', a new requirement was imposed that all criticality safety controls be evaluated for inclusion in the facility Documented Safety Analysis (DSA) and that the evaluation process be documented in the site Criticality Safety Program Description Document (CSPDD). At the Hanford site in Washington State the CSPDD, HNF-31695, 'General Description of the FH Criticality Safety Program', requires each facility develop a linking document called a Criticality Control Review (CCR) to document performance of these evaluations. Chapter 5,more » Appendix 5B of HNF-7098, Criticality Safety Program, provided an example of a format for a CCR that could be used in lieu of each facility developing its own CCR. Since the Plutonium Finishing Plant (PFP) is presently undergoing Deactivation and Decommissioning (D&D), new procedures are being developed for cleanout of equipment and systems that have not been operated in years. Existing Criticality Safety Evaluations (CSE) are revised, or new ones written, to develop the controls required to support D&D activities. Other Hanford facilities, including PFP, had difficulty using the basic CCR out of HNF-7098 when first implemented. Interpretation of the new guidelines indicated that many of the controls needed to be elevated to TSR level controls. Criterion 2 of the standard, requiring that the consequence of a criticality be examined for establishing the classification of a control, was not addressed. Upon in-depth review by PFP Criticality Safety staff, it was not clear that the programmatic interpretation of criterion 8C could be applied at PFP. Therefore, the PFP Criticality Safety staff decided to write their own CCR. The PFP CCR provides additional guidance for the evaluation team to use by clarifying the evaluation criteria in DOE-STD-3007-2007. In reviewing documents used in classifying controls for Nuclear Safety, it was noted that DOE-HDBK-1188, 'Glossary of Environment, Health, and Safety Terms', defines an Administrative Control (AC) in terms that are different than typically used in Criticality Safety. As part of this CCR, a new term, Criticality Administrative Control (CAC) was defined to clarify the difference between an AC used for criticality safety and an AC used for nuclear safety. In Nuclear Safety terms, an AC is a provision relating to organization and management, procedures, recordkeeping, assessment, and reporting necessary to ensure safe operation of a facility. A CAC was defined as an administrative control derived in a criticality safety analysis that is implemented to ensure double contingency. According to criterion 2 of Section IV, 'Linkage to the Documented Safety Analysis', of DOESTD-3007-2007, the consequence of a criticality should be examined for the purposes of classifying the significance of a control or component. HNF-PRO-700, 'Safety Basis Development', provides control selection criteria based on consequence and risk that may be used in the development of a Criticality Safety Evaluation (CSE) to establish the classification of a component as a design feature, as safety class or safety significant, i.e., an Engineered Safety Feature (ESF), or as equipment important to safety; or merely provides defense-in-depth. Similar logic is applied to the CACs. Criterion 8C of DOE-STD-3007-2007, as written, added to the confusion of using the basic CCR from HNF-7098. The PFP CCR attempts to clarify this criterion by revising it to say 'Programmatic commitments or general references to control philosophy (e.g., mass control or spacing control or concentration control as an overall control strategy for the process without specific quantification of individual limits) is included in the PFP DSA'. Table 1 shows the PFP methodology for evaluating CACs. This evaluation process has been in use since February of 2008 and has proven to be simple and effective. Each control identified in the applicable new/revised CSE is evaluated via the table. The results of this evaluation are documented in tables attached to the CCR as an appendix, for each CSE, to the base document.« less

Safety performance evaluation of converging chevron pavement markings : final report.

DOT National Transportation Integrated Search

2014-12-01

The objectives of this study were (1) to perform a detailed safety analysis of converging chevron : pavement markings, quantifying the potential safety benefits and developing an understanding of the : incident types addressed by the treatment, and (...

Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

PubMed

Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

2017-03-15

Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

Railway safety climate: a study on organizational development.

PubMed

Cheng, Yung-Hsiang

2017-09-07

The safety climate of an organization is considered a leading indicator of potential risk for railway organizations. This study adopts the perceptual measurement-individual attribute approach to investigate the safety climate of a railway organization. The railway safety climate attributes are evaluated from the perspective of railway system staff. We identify four safety climate dimensions from exploratory factor analysis, namely safety communication, safety training, safety management and subjectively evaluated safety performance. Analytical results indicate that the safety climate differs at vertical and horizontal organizational levels. This study contributes to the literature by providing empirical evidence of the multilevel safety climate in a railway organization, presents possible causes of the differences under various cultural contexts and differentiates between safety climate scales for diverse workgroups within the railway organization. This information can be used to improve the safety sustainability of railway organizations and to conduct safety supervisions for the government.

Modelling safety of multistate systems with ageing components

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kołowrocki, Krzysztof; Soszyńska-Budny, Joanna

An innovative approach to safety analysis of multistate ageing systems is presented. Basic notions of the ageing multistate systems safety analysis are introduced. The system components and the system multistate safety functions are defined. The mean values and variances of the multistate systems lifetimes in the safety state subsets and the mean values of their lifetimes in the particular safety states are defined. The multi-state system risk function and the moment of exceeding by the system the critical safety state are introduced. Applications of the proposed multistate system safety models to the evaluation and prediction of the safty characteristics ofmore » the consecutive “m out of n: F” is presented as well.« less

10 CFR 52.79 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2010 CFR

2010-01-01

... assurance program will be implemented; (26) The applicant's organizational structure, allocations or... presents a safety analysis of the structures, systems, and components of the facility as a whole. The final... contain an analysis and evaluation of the major structures, systems, and components of the facility that...

Potential safety benefits of intelligent cruise control systems.

PubMed

Chira-Chavala, T; Yoo, S M

1994-04-01

Potential safety impact of a hypothetical intelligent cruise control system (ICCS) is evaluated in terms of changes in traffic accidents and some traffic operation characteristics affecting safety. The analysis of changes in traffic accidents is accomplished by in-depth examinations of police accident reports for four major counties in California. The evaluation of changes in traffic operation characteristics affecting safety is accomplished by vehicle simulation. The accident analysis reveals that the use of the hypothetical ICCS could potentially reduce traffic accidents by up to 7.5%. Preliminary vehicle simulation results based on a 10-vehicle convoy indicate that the use of the hypothetical ICCS could reduce frequencies of hard acceleration and deceleration, enhance speed harmonization among vehicles, and reduce incidence of "less-safe" headway.

Implementation of a patient safety program at a tertiary health system: A longitudinal analysis of interventions and serious safety events.

PubMed

Cropper, Douglas P; Harb, Nidal H; Said, Patricia A; Lemke, Jon H; Shammas, Nicolas W

2018-04-01

We hypothesize that implementation of a safety program based on high reliability organization principles will reduce serious safety events (SSE). The safety program focused on 7 essential elements: (a) safety rounding, (b) safety oversight teams, (c) safety huddles, (d) safety coaches, (e) good catches/safety heroes, (f) safety education, and (g) red rule. An educational curriculum was implemented focusing on changing high-risk behaviors and implementing critical safety policies. All unusual occurrences were captured in the Midas system and investigated by risk specialists, the safety officer, and the chief medical officer. A multidepartmental committee evaluated these events, and a root cause analysis (RCA) was performed. Events were tabulated and serious safety event (SSE) recorded and plotted over time. Safety success stories (SSSs) were also evaluated over time. A steady drop in SSEs was seen over 9 years. Also a rise in SSSs was evident, reflecting on staff engagement in the program. The parallel change in SSEs, SSSs, and the implementation of various safety interventions highly suggest that the program was successful in achieving its goals. A safety program based on high-reliability organization principles and made a core value of the institution can have a significant positive impact on reducing SSEs. © 2018 American Society for Healthcare Risk Management of the American Hospital Association.

Evaluation of the US Department of Energy's occupational safety and health program for its government-owned contractor-operated facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

The purpose of this report is to present to Secretary of Energy James Watkins the findings and recommendations of the Occupational Safety and Health Administration's (OSHA) evaluation of the Department of Energy's (DOE) programs for worker safety and health at DOE's government-owned contractor-operated (GOCO) nuclear facilities. The OSHA evaluation is based on an intensive and comprehensive review and analysis of DOE's worker safety and health programs including: written programs; safety and health inspection programs; and the adequacy of resource, training, and management controls. The evaluation began on April 10, 1990 and involved over three staff years before its conclusion. Themore » evaluation was initiated by former Secretary of Labor Elizabeth Dole in response to Secretary of Energy James Watkins' request that OSHA assist him in determining the actions needed to assure that DOE has an exemplary safety and health program in place at its GOCOs. 6 figs.« less

Effectiveness of maritime safety control in different navigation zones using a spatial sequential DEA model: Yangtze River case.

PubMed

Wu, Bing; Wang, Yang; Zhang, Jinfen; Savan, Emanuel Emil; Yan, Xinping

2015-08-01

This paper aims to analyze the effectiveness of maritime safety control from the perspective of safety level along the Yangtze River with special considerations for navigational environments. The influencing variables of maritime safety are reviewed, including ship condition, maritime regulatory system, human reliability and navigational environment. Because the former three variables are generally assumed to be of the same level of safety, this paper focuses on studying the impact of navigational environments on the level of safety in different waterways. An improved data envelopment analysis (DEA) model is proposed by treating the navigational environment factors as inputs and ship accident data as outputs. Moreover, because the traditional DEA model cannot provide an overall ranking of different decision making units (DMUs), the spatial sequential frontiers and grey relational analysis are incorporated into the DEA model to facilitate a refined assessment. Based on the empirical study results, the proposed model is able to solve the problem of information missing in the prior models and evaluate the level of safety with a better accuracy. The results of the proposed DEA model are further compared with an evidential reasoning (ER) method, which has been widely used for level of safety evaluations. A sensitivity analysis is also conducted to better understand the relationship between the variation of navigational environments and level of safety. The sensitivity analysis shows that the level of safety varies in terms of traffic flow. It indicates that appropriate traffic control measures should be adopted for different waterways to improve their safety. This paper presents a practical method of conducting maritime level of safety assessments under dynamic navigational environment. Copyright © 2015 Elsevier Ltd. All rights reserved.

In-space propellant logistics. Volume 1: Executive summary

NASA Technical Reports Server (NTRS)

1972-01-01

The study addresses the systems and operational problems associated with the transport, transfer, and storage of cryogenic propellants in low earth orbits. The safety problems connected with in-space propellant logistics operations are also considered.Correlation between the two projects was maintained by including safety considerations, resulting from the system safety analysis, in the trade studies and evaluations of alternate operating concepts in the systems operations analysis.

Nuclear criticality safety evaluation of SRS 9971 shipping package

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vescovi, P.J.

1993-02-01

This evaluation is requested to revise the criticality evaluation used to generate Chapter 6 (Criticality Evaluation) of the Safety Analysis Report for Packaging (SARP) for shipment Of UO{sub 3} product from the Uranium Solidification Facility (USF) in the SRS 9971 shipping package. The pertinent document requesting this evaluation is included as Attachment I. The results of the evaluation are given in Attachment II which is written as Chapter 6 of a NRC format SARP.

75 FR 63609 - Oil and Gas and Sulphur Operations in the Outer Continental Shelf-Safety and Environmental...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-15

... safety of the offshore facility, including ensuring that all contractors and subcontractors have safety... safety analysis (task level); (3) Procedures to verify that contractors are conducting their activities in accordance with the operator's SEMS program and an evaluation to ensure that contractors have the...

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

The relationship of alcohol safety laws to drinking drivers in fatal crashes

DOT National Transportation Integrated Search

1999-08-01

This paper presents an analysis of the relationships between the passage of key alcohol safety laws and the number of drinking drivers in fatal crashes. The study evaluated the impact of three major alcohol safety laws (administrative license revocat...

An Independent Evaluation of the FMEA/CIL Hazard Analysis Alternative Study

NASA Technical Reports Server (NTRS)

Ray, Paul S.

1996-01-01

The present instruments of safety and reliability risk control for a majority of the National Aeronautics and Space Administration (NASA) programs/projects consist of Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA), Critical Items List (CIL), and Hazard Report (HR). This extensive analytical approach was introduced in the early 1970's and was implemented for the Space Shuttle Program by NHB 5300.4 (1D-2. Since the Challenger accident in 1986, the process has been expanded considerably and resulted in introduction of similar and/or duplicated activities in the safety/reliability risk analysis. A study initiated in 1995, to search for an alternative to the current FMEA/CIL Hazard Analysis methodology generated a proposed method on April 30, 1996. The objective of this Summer Faculty Study was to participate in and conduct an independent evaluation of the proposed alternative to simplify the present safety and reliability risk control procedure.

[Development and validation of the Korean patient safety culture scale for nursing homes].

PubMed

Yoon, Sook Hee; Kim, Byungsoo; Kim, Se Young

2013-06-01

The purpose of this study was to develop a tool to evaluate patient safety culture in nursing homes and to test its validity and reliability. A preliminary tool was developed through interviews with focus group, content validity tests, and a pilot study. A nationwide survey was conducted from February to April, 2011, using self-report questionnaires. Participants were 982 employees in nursing homes. Data were analyzed using Cronbach's alpha, item analysis, factor analysis, and multitrait/multi-Item analysis. From the results of the analysis, 27 final items were selected from 49 items on the preliminary tool. Items with low correlation with total scale were excluded. The 4 factors sorted by factor analysis contributed 63.4% of the variance in the total scale. The factors were labeled as leadership, organizational system, working attitude, management practice. Cronbach's alpha for internal consistency was .95 and the range for the 4 factors was from .86 to .93. The results of this study indicate that the Korean Patient Safety Culture Scale has reliability and validity and is suitable for evaluation of patient safety culture in Korean nursing homes.

Safety analysis report for packaging (onsite) steel drum

DOE Office of Scientific and Technical Information (OSTI.GOV)

McCormick, W.A.

This Safety Analysis Report for Packaging (SARP) provides the analyses and evaluations necessary to demonstrate that the steel drum packaging system meets the transportation safety requirements of HNF-PRO-154, Responsibilities and Procedures for all Hazardous Material Shipments, for an onsite packaging containing Type B quantities of solid and liquid radioactive materials. The basic component of the steel drum packaging system is the 208 L (55-gal) steel drum.

Nuclear criticality safety evaluation of SRS 9971 shipping package. [SRS (Savannah River Site)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vescovi, P.J.

1993-02-01

This evaluation is requested to revise the criticality evaluation used to generate Chapter 6 (Criticality Evaluation) of the Safety Analysis Report for Packaging (SARP) for shipment Of UO[sub 3] product from the Uranium Solidification Facility (USF) in the SRS 9971 shipping package. The pertinent document requesting this evaluation is included as Attachment I. The results of the evaluation are given in Attachment II which is written as Chapter 6 of a NRC format SARP.

Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.

2013-11-07

A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25more » recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.« less

An analysis of problem drinker diagnosis and referral within the Fairfax Alcohol Safety Action Project, 1972.

DOT National Transportation Integrated Search

1974-01-01

This report is one of a series developed in conformance with annual reporting requirements contained within Alcohol Safety Action Projects: Evaluation. In February 1972, operations of the Fairfax Alcohol Safety Action Project began and these federall...

Evaluation of analytical methodology for hydrocarbons in high pressure air and nitrogen systems. [data aquisition

NASA Technical Reports Server (NTRS)

1977-01-01

Information regarding the safety limits of hydrocarbons in liquid and gaseous oxygen, the steps taken for hydrocarbon removal from liquified gases, and the analysis of the contaminants was searched and the results are presented. The safety of hydrocarbons in gaseous systems was studied, and the latest hydrocarbon test equipment and methodology is reviewed. A detailed sampling and analysis plan is proposed to evaluate high pressure GN2 and LOX systems.

Regulatory assessment with regulatory flexibility analysis : draft regulatory evaluation - Notice of Proposed Rulemaking -- Pipeline Safety : safety standards for increasing the maximum allowable operating pressure for natural gas transmission pipelines.

DOT National Transportation Integrated Search

2008-02-01

The Pipeline and Hazardous Materials Safety Administration (PHMSA) is proposing changes to the Federal pipeline safety regulations in 49 CFR Part 192, which cover the transportation of natural gas by pipeline. Specifically, PHMSA proposes allowing na...

ARAMIS project: a more explicit demonstration of risk control through the use of bow-tie diagrams and the evaluation of safety barrier performance.

PubMed

de Dianous, Valérie; Fiévez, Cécile

2006-03-31

Over the last two decades a growing interest for risk analysis has been noted in the industries. The ARAMIS project has defined a methodology for risk assessment. This methodology has been built to help the industrialist to demonstrate that they have a sufficient risk control on their site. Risk analysis consists first in the identification of all the major accidents, assuming that safety functions in place are inefficient. This step of identification of the major accidents uses bow-tie diagrams. Secondly, the safety barriers really implemented on the site are taken into account. The barriers are identified on the bow-ties. An evaluation of their performance (response time, efficiency, and level of confidence) is performed to validate that they are relevant for the expected safety function. At last, the evaluation of their probability of failure enables to assess the frequency of occurrence of the accident. The demonstration of the risk control based on a couple gravity/frequency of occurrence is also possible for all the accident scenarios. During the risk analysis, a practical tool called risk graph is used to assess if the number and the reliability of the safety functions for a given cause are sufficient to reach a good risk control.

A fully Bayesian before-after analysis of permeable friction course (PFC) pavement wet weather safety.

PubMed

Buddhavarapu, Prasad; Smit, Andre F; Prozzi, Jorge A

2015-07-01

Permeable friction course (PFC), a porous hot-mix asphalt, is typically applied to improve wet weather safety on high-speed roadways in Texas. In order to warrant expensive PFC construction, a statistical evaluation of its safety benefits is essential. Generally, the literature on the effectiveness of porous mixes in reducing wet-weather crashes is limited and often inconclusive. In this study, the safety effectiveness of PFC was evaluated using a fully Bayesian before-after safety analysis. First, two groups of road segments overlaid with PFC and non-PFC material were identified across Texas; the non-PFC or reference road segments selected were similar to their PFC counterparts in terms of site specific features. Second, a negative binomial data generating process was assumed to model the underlying distribution of crash counts of PFC and reference road segments to perform Bayesian inference on the safety effectiveness. A data-augmentation based computationally efficient algorithm was employed for a fully Bayesian estimation. The statistical analysis shows that PFC is not effective in reducing wet weather crashes. It should be noted that the findings of this study are in agreement with the existing literature, although these studies were not based on a fully Bayesian statistical analysis. Our study suggests that the safety effectiveness of PFC road surfaces, or any other safety infrastructure, largely relies on its interrelationship with the road user. The results suggest that the safety infrastructure must be properly used to reap the benefits of the substantial investments. Copyright © 2015 Elsevier Ltd. All rights reserved.

76 FR 37852 - Advisory Committee on Reactor Safeguards; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-28

... Thursday, October 21, 2010 (74 FR 65038-65039). Wednesday, July 13, 2011, Conference Room T2-B1, 11545....: Safety Evaluation Report Associated with NEDC-33173, Supplement 2, Parts 1, 2, and 3, ``Analysis of Gamma... Electric Hitachi (GEH) regarding the safety evaluation report associated with NEDC-33173, Supplement 2...

A 1064 nm dispersive Raman spectral imaging system for food safety and quality evaluation

USDA-ARS?s Scientific Manuscript database

Raman spectral imaging is an effective method to analyze and evaluate chemical composition and structure of a sample, and has many applications for food safety and quality research. This study developed a 1064 nm Raman spectral imaging system for surface and subsurface analysis of food samples. A 10...

Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessment.

PubMed

Hammad, Tarek A; Neyarapally, George A; Pinheiro, Simone P; Iyasu, Solomon; Rochester, George; Dal Pan, Gerald

2013-01-01

Due to the sparse nature of serious drug-related adverse events (AEs), meta-analyses combining data from several randomized controlled trials (RCTs) to evaluate drug safety issues are increasingly being conducted and published, influencing clinical and regulatory decision making. Evaluation of meta-analyses involves the assessment of both the individual constituent trials and the approaches used to combine them. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting framework is designed to enhance the reporting of systematic reviews and meta-analyses. However, PRISMA may not cover all critical elements useful in the evaluation of meta-analyses with a focus on drug safety particularly in the regulatory-public health setting. This work was conducted to (1) evaluate the adherence of a sample of published drug safety-focused meta-analyses to the PRISMA reporting framework, (2) identify gaps in this framework based on key aspects pertinent to drug safety, and (3) stimulate the development and validation of a more comprehensive reporting tool that incorporates elements unique to drug safety evaluation. We selected a sample of meta-analyses of RCTs based on review of abstracts from high-impact journals as well as top medical specialty journals between 2009 and 2011. We developed a preliminary reporting framework based on PRISMA with specific additional reporting elements critical for the evaluation of drug safety meta-analyses of RCTs. The reporting of pertinent elements in each meta-analysis was reviewed independently by two authors; discrepancies in the independent evaluations were resolved through discussions between the two authors. A total of 27 meta-analyses, 12 from highest impact journals, 13 from specialty medical journals, and 2 from Cochrane reviews, were identified and evaluated. The great majority (>85%) of PRISMA elements were addressed in more than half of the meta-analyses reviewed. However, the majority of meta-analyses (>60%) did not address most (>80%) of the additional reporting elements critical for the evaluation of drug safety. Some of these elements were not addressed in any of the reviewed meta-analyses. This review included a sample of meta-analyses, with a focus on drug safety, recently published in high-impact journals; therefore, we may have underestimated the extent of the reporting problem across all meta-analyses of drug safety. Furthermore, temporal trends in reporting could not be evaluated in this review because of the short time interval selected. While the majority of PRISMA elements were addressed by most studies reviewed, the majority of studies did not address most of the additional safety-related elements. These findings highlight the need for the development and validation of a drug safety reporting framework and the importance of the current initiative by the Council for International Organizations of Medical Sciences (CIOMS) to create a guidance document for drug safety information synthesis/meta-analysis, which may improve reporting, conduct, and evaluation of meta-analyses of drug safety and inform clinical and regulatory decision making.

Applicability of the Common Safety Method for Risk Evaluation and Assessment (CSM-RA) to the Space Domain

NASA Astrophysics Data System (ADS)

Moreira, Francisco; Silva, Nuno

2016-08-01

Safety systems require accident avoidance. This is covered by application standards, processes, techniques and tools that support the identification, analysis, elimination or reduction to an acceptable level of system risks and hazards. Ideally, a safety system should be free of hazards. However, both industry and academia have been struggling to ensure appropriate risk and hazard analysis, especially in what concerns completeness of the hazards, formalization, and timely analysis in order to influence the specifications and the implementation. Such analysis is also important when considering a change to an existing system. The Common Safety Method for Risk Evaluation and Assessment (CSM- RA) is a mandatory procedure whenever any significant change is proposed to the railway system in a European Member State. This paper provides insights on the fundamentals of CSM-RA based and complemented with Hazard Analysis. When and how to apply them, and the relation and similarities of these processes with industry standards and the system life cycles is highlighted. Finally, the paper shows how CSM-RA can be the basis of a change management process, guiding the identification and management of the hazards helping ensuring the similar safety level as the initial system. This paper will show how the CSM-RA principles can be used in other domains particularly for space system evolution.

Integrated risk assessment and screening analysis of drinking water safety of a conventional water supply system.

PubMed

Sun, F; Chen, J; Tong, Q; Zeng, S

2007-01-01

Management of drinking water safety is changing towards an integrated risk assessment and risk management approach that includes all processes in a water supply system from catchment to consumers. However, given the large number of water supply systems in China and the cost of implementing such a risk assessment procedure, there is a necessity to first conduct a strategic screening analysis at a national level. An integrated methodology of risk assessment and screening analysis is thus proposed to evaluate drinking water safety of a conventional water supply system. The violation probability, indicating drinking water safety, is estimated at different locations of a water supply system in terms of permanganate index, ammonia nitrogen, turbidity, residual chlorine and trihalomethanes. Critical parameters with respect to drinking water safety are then identified, based on which an index system is developed to prioritize conventional water supply systems in implementing a detailed risk assessment procedure. The evaluation results are represented as graphic check matrices for the concerned hazards in drinking water, from which the vulnerability of a conventional water supply system is characterized.

Aluminum Data Measurements and Evaluation for Criticality Safety Applications

NASA Astrophysics Data System (ADS)

Leal, L. C.; Guber, K. H.; Spencer, R. R.; Derrien, H.; Wright, R. Q.

2002-12-01

The Defense Nuclear Facility Safety Board (DNFSB) Recommendation 93-2 motivated the US Department of Energy (DOE) to develop a comprehensive criticality safety program to maintain and to predict the criticality of systems throughout the DOE complex. To implement the response to the DNFSB Recommendation 93-2, a Nuclear Criticality Safety Program (NCSP) was created including the following tasks: Critical Experiments, Criticality Benchmarks, Training, Analytical Methods, and Nuclear Data. The Nuclear Data portion of the NCSP consists of a variety of differential measurements performed at the Oak Ridge Electron Linear Accelerator (ORELA) at the Oak Ridge National Laboratory (ORNL), data analysis and evaluation using the generalized least-squares fitting code SAMMY in the resolved, unresolved, and high energy ranges, and the development and benchmark testing of complete evaluations for a nuclide for inclusion into the Evaluated Nuclear Data File (ENDF/B). This paper outlines the work performed at ORNL to measure, evaluate, and test the nuclear data for aluminum for applications in criticality safety problems.

Integrated Response Time Evaluation Methodology for the Nuclear Safety Instrumentation System

NASA Astrophysics Data System (ADS)

Lee, Chang Jae; Yun, Jae Hee

2017-06-01

Safety analysis for a nuclear power plant establishes not only an analytical limit (AL) in terms of a measured or calculated variable but also an analytical response time (ART) required to complete protective action after the AL is reached. If the two constraints are met, the safety limit selected to maintain the integrity of physical barriers used for preventing uncontrolled radioactivity release will not be exceeded during anticipated operational occurrences and postulated accidents. Setpoint determination methodologies have actively been developed to ensure that the protective action is initiated before the process conditions reach the AL. However, regarding the ART for a nuclear safety instrumentation system, an integrated evaluation methodology considering the whole design process has not been systematically studied. In order to assure the safety of nuclear power plants, this paper proposes a systematic and integrated response time evaluation methodology that covers safety analyses, system designs, response time analyses, and response time tests. This methodology is applied to safety instrumentation systems for the advanced power reactor 1400 and the optimized power reactor 1000 nuclear power plants in South Korea. The quantitative evaluation results are provided herein. The evaluation results using the proposed methodology demonstrate that the nuclear safety instrumentation systems fully satisfy corresponding requirements of the ART.

Safety evaluation methodology for advanced coal extraction systems

NASA Technical Reports Server (NTRS)

Zimmerman, W. F.

1981-01-01

Qualitative and quantitative evaluation methods for coal extraction systems were developed. The analysis examines the soundness of the design, whether or not the major hazards have been eliminated or reduced, and how the reduction would be accomplished. The quantitative methodology establishes the approximate impact of hazards on injury levels. The results are weighted by peculiar geological elements, specialized safety training, peculiar mine environmental aspects, and reductions in labor force. The outcome is compared with injury level requirements based on similar, safer industries to get a measure of the new system's success in reducing injuries. This approach provides a more detailed and comprehensive analysis of hazards and their effects than existing safety analyses.

Method of Evaluating the Life Cycle Cost of Small Earth Dams Considering the Risk of Heavy Rainfall and Selection Method of the Optimum Countermeasure

NASA Astrophysics Data System (ADS)

Hori, Toshikazu; Mohri, Yoshiyuki; Matsushima, Kenichi; Ariyoshi, Mitsuru

In recent years the increase in the number of heavy rainfall occurrences such as through unpredictable cloudbursts have resulted in the safety of the embankments of small earth dams needing to be improved. However, the severe financial condition of the government and local autonomous bodies necessitate the cost of improving them to be reduced. This study concerns the development of a method of evaluating the life cycle cost of small earth dams considered to pose a risk and in order to improve the safety of the downstream areas of small earth dams at minimal cost. Use of a safety evaluation method that is based on a combination of runoff analysis, saturated and unsaturated seepage analysis, and slope stability analysis enables the probability of a dam breach and its life cycle cost with the risk of heavy rainfall taken into account to be calculated. Moreover, use of the life cycle cost evaluation method will lead to the development of a technique for selecting the method of the optimal improvement or countermeasures against heavy rainfall.

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2010 CFR

2010-01-01

... analysis of the structures, systems, and components of the reactor to be manufactured, with emphasis upon... assumed for this evaluation should be based upon a major accident, hypothesized for purposes of site... structures, systems, and components with the objective of assessing the risk to public health and safety...

Triangulation and the importance of establishing valid methods for food safety culture evaluation.

PubMed

Jespersen, Lone; Wallace, Carol A

2017-10-01

The research evaluates maturity of food safety culture in five multi-national food companies using method triangulation, specifically self-assessment scale, performance documents, and semi-structured interviews. Weaknesses associated with each individual method are known but there are few studies in food safety where a method triangulation approach is used for both data collection and data analysis. Significantly, this research shows that individual results taken in isolation can lead to wrong conclusions, resulting in potentially failing tactics and wasted investments. However, by applying method triangulation and reviewing results from a range of culture measurement tools it is possible to better direct investments and interventions. The findings add to the food safety culture paradigm beyond a single evaluation of food safety culture using generic culture surveys. Copyright © 2017. Published by Elsevier Ltd.

Investigation of safety analysis methods using computer vision techniques

NASA Astrophysics Data System (ADS)

Shirazi, Mohammad Shokrolah; Morris, Brendan Tran

2017-09-01

This work investigates safety analysis methods using computer vision techniques. The vision-based tracking system is developed to provide the trajectory of road users including vehicles and pedestrians. Safety analysis methods are developed to estimate time to collision (TTC) and postencroachment time (PET) that are two important safety measurements. Corresponding algorithms are presented and their advantages and drawbacks are shown through their success in capturing the conflict events in real time. The performance of the tracking system is evaluated first, and probability density estimation of TTC and PET are shown for 1-h monitoring of a Las Vegas intersection. Finally, an idea of an intersection safety map is introduced, and TTC values of two different intersections are estimated for 1 day from 8:00 a.m. to 6:00 p.m.

Evaluation of the CSA 2010 operational model test.

DOT National Transportation Integrated Search

2011-08-01

"In accordance with its primary mission to reduce crashes, injuries, and fatalities involving large trucks and buses, the Federal Motor Carrier Safety Administration (FMCSA) initiated the Comprehensive Safety Analysis 2010 (CSA 2010) Operational Mode...

An evaluation of Ontario's Group Education Session (GES) for license renewal of seniors aged 80 and above.

PubMed

Vanlaar, Ward; Hing, Marisela Mainegra; Robertson, Robyn; Mayhew, Dan; Carr, David

2016-02-01

In 1996, the Ministry of Transportation in Ontario (MTO) implemented the Group Education Session (GES), which is a mandatory license renewal program for drivers aged 80 and older. This study describes an evaluation of the GES to assess its impact on road safety in Ontario, as well as its effect on the safety of individual drivers who participated in the program. Time series analysis of senior driver records both before and after implementation of the GES, and logistic regression and survival analysis examining senior driver records prior to, and following, their participation in the GES. Using time series analysis there is some evidence to suggest that the GES had a positive impact on road safety. According to the other analyses, participation in the GES is associated with a decrease in the odds of collisions and convictions, regardless of whether drivers pass their first attempt of the knowledge test or not. In addition, failing the first road test and/or having demerit points are strong indicators of future collision and conviction involvement. Results from this evaluation suggest that the GES has had a protective effect on the safety of senior drivers. The findings and discussion will help MTO improve the GES program and provide insights to other jurisdictions that have, or are considering, introducing new senior driver programs. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

An Educational Intervention to Enhance Nurse Leaders' Perceptions of Patient Safety Culture

PubMed Central

Ginsburg, Liane; Norton, Peter G; Casebeer, Ann; Lewis, Steven

2005-01-01

Objective To design a training intervention and then test its effect on nurse leaders' perceptions of patient safety culture. Study Setting Three hundred and fifty-six nurses in clinical leadership roles (nurse managers and educators/CNSs) in two Canadian multi-site teaching hospitals (study and control). Study Design A prospective evaluation of a patient safety training intervention using a quasi-experimental untreated control group design with pretest and posttest. Nurses in clinical leadership roles in the study group were invited to participate in two patient safety workshops over a 6-month period. Individuals in the study and control groups completed surveys measuring patient safety culture and leadership for improvement prior to training and 4 months following the second workshop. Extraction Methods Individual nurse clinical leaders were the unit of analysis. Exploratory factor analysis of the safety culture items was conducted; repeated-measures analysis of variance and paired t-tests were used to evaluate the effect of the training intervention on perceived safety culture (three factors). Hierarchical regression analyses looked at the influence of demographics, leadership for improvement, and the training intervention on nurse leaders' perceptions of safety culture. Principal Findings A statistically significant improvement in one of three safety culture measures was shown for the study group (p<.001) and a significant decline was seen on one of the safety culture measures for the control group (p<.05). Leadership support for improvement was found to explain significant amounts of variance in all three patient safety culture measures; workshop attendance explained significant amounts of variance in one of the three safety culture measures. The total R2 for the three full hierarchical regression models ranged from 0.338 and 0.554. Conclusions Sensitively delivered training initiatives for nurse leaders can help to foster a safety culture. Organizational leadership support for improvement is, however, also critical for fostering a culture of safety. Together, training interventions and leadership support may have the most significant impact on patient safety culture. PMID:16033489

Safety analysis report for packaging (onsite) multicanister overpack cask

DOE Office of Scientific and Technical Information (OSTI.GOV)

Edwards, W.S.

1997-07-14

This safety analysis report for packaging (SARP) documents the safety of shipments of irradiated fuel elements in the MUlticanister Overpack (MCO) and MCO Cask for a highway route controlled quantity, Type B fissile package. This SARP evaluates the package during transfers of (1) water-filled MCOs from the K Basins to the Cold Vacuum Drying Facility (CVDF) and (2) sealed and cold vacuum dried MCOs from the CVDF in the 100 K Area to the Canister Storage Building in the 200 East Area.

The Decision Making Trial and Evaluation Laboratory (Dematel) and Analytic Network Process (ANP) for Safety Management System Evaluation Performance

NASA Astrophysics Data System (ADS)

Rolita, Lisa; Surarso, Bayu; Gernowo, Rahmat

2018-02-01

In order to improve airport safety management system (SMS) performance, an evaluation system is required to improve on current shortcomings and maximize safety. This study suggests the integration of the DEMATEL and ANP methods in decision making processes by analyzing causal relations between the relevant criteria and taking effective analysis-based decision. The DEMATEL method builds on the ANP method in identifying the interdependencies between criteria. The input data consists of questionnaire data obtained online and then stored in an online database. Furthermore, the questionnaire data is processed using DEMATEL and ANP methods to obtain the results of determining the relationship between criteria and criteria that need to be evaluated. The study cases on this evaluation system were Adi Sutjipto International Airport, Yogyakarta (JOG); Ahmad Yani International Airport, Semarang (SRG); and Adi Sumarmo International Airport, Surakarta (SOC). The integration grades SMS performance criterion weights in a descending order as follow: safety and destination policy, safety risk management, healthcare, and safety awareness. Sturges' formula classified the results into nine grades. JOG and SMG airports were in grade 8, while SOG airport was in grade 7.

Evaluation of the CSA 2010 Operational Model Test: Full Report

DOT National Transportation Integrated Search

2011-08-01

In accordance with its primary mission to reduce crashes, injuries, and fatalities involving large trucks and buses, the Federal Motor Carrier Safety Administration (FMCSA) initiated the Comprehensive Safety Analysis 2010 (CSA 2010) Operational Model...

Ethnomedical survey and safety evaluation of traditional eye medicines used in Misungwi district, Tanzania

PubMed Central

Maregesi, Sheila M.; Messo, Charles W.; Mathias, Juma

2017-01-01

Aim: This study aimed at documenting products used as traditional eye medicine (TEM) in Misungwi district, Tanzania, and performing preliminary analysis on safety status. Methodology: Ethnomedical study was conducted in Misungwi district. Information was sourced by face-to-face interview with traditional healers, traditional medicine vendors, and knowledgeable people guided by a well-structured questionnaire. Safety was evaluated by determining pH using pH meter and mineral analysis using the Delta, Portable X-ray fluorescence equipment, and qualitative chemical tests. Results: A total of 23 TEM products were recorded from botanical (79%) and zoological (21%) sources including animal excreta. Liquid preparation ranked highest among dosage forms. Safety evaluation showed that only one product possessed the pH value of 7.4 as recommended for topical ophthalmic medicines. Fourteen minerals were detected and quantified in three samples; some of these minerals are known for their negative effects to the eyes, of medical interest is strontium used for the management of benign eye tumors. Information providers were unaware of health risks associated with the use of TEM. Conclusion: This study has revealed the common use of TEM in Misungwi district. The majority of the products are from the botanical source. Although literature provides supporting data for the application to some of the recorded TEM, safety evaluation by pH and mineral analysis in this study have indicated possible ophthalmological medical problems that could result from using such products. Extensive scientific studies including animal experiments and identification of bioactive compounds are essential to develop safe TEMs. PMID:28163964

Final safety analysis report for the Galileo Mission: Volume 1, Reference design document

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

The Galileo mission uses nuclear power sources called Radioisotope Thermoelectric Generators (RTGs) to provide the spacecraft's primary electrical power. Because these generators contain nuclear material, a Safety Analysis Report (SAR) is required. A preliminary SAR and an updated SAR were previously issued that provided an evolving status report on the safety analysis. As a result of the Challenger accident, the launch dates for both Galileo and Ulysses missions were later rescheduled for November 1989 and October 1990, respectively. The decision was made by agreement between the DOE and the NASA to have a revised safety evaluation and report (FSAR) preparedmore » on the basis of these revised vehicle accidents and environments. The results of this latest revised safety evaluation are presented in this document (Galileo FSAR). Volume I, this document, provides the background design information required to understand the analyses presented in Volumes II and III. It contains descriptions of the RTGs, the Galileo spacecraft, the Space Shuttle, the Inertial Upper Stage (IUS), the trajectory and flight characteristics including flight contingency modes, and the launch site. There are two appendices in Volume I which provide detailed material properties for the RTG.« less

MODEL 9977 B(M)F-96 SAFETY ANALYSIS REPORT FOR PACKAGING

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abramczyk, G; Paul Blanton, P; Kurt Eberl, K

2006-05-18

This Safety Analysis Report for Packaging (SARP) documents the analysis and testing performed on and for the 9977 Shipping Package, referred to as the General Purpose Fissile Package (GPFP). The performance evaluation presented in this SARP documents the compliance of the 9977 package with the regulatory safety requirements for Type B packages. Per 10 CFR 71.59, for the 9977 packages evaluated in this SARP, the value of ''N'' is 50, and the Transport Index based on nuclear criticality control is 1.0. The 9977 package is designed with a high degree of single containment. The 9977 complies with 10 CFR 71more » (2002), Department of Energy (DOE) Order 460.1B, DOE Order 460.2, and 10 CFR 20 (2003) for As Low As Reasonably Achievable (ALARA) principles. The 9977 also satisfies the requirements of the Regulations for the Safe Transport of Radioactive Material--1996 Edition (Revised)--Requirements. IAEA Safety Standards, Safety Series No. TS-R-1 (ST-1, Rev.), International Atomic Energy Agency, Vienna, Austria (2000). The 9977 package is designed, analyzed and fabricated in accordance with Section III of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel (B&PV) Code, 1992 edition.« less

Safety culture assessment in petrochemical industry: a comparative study of two algerian plants.

PubMed

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-06-01

To elucidate the relationship between safety culture maturity and safety performance of a particular company. To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

Safety Culture Assessment in Petrochemical Industry: A Comparative Study of Two Algerian Plants

PubMed Central

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-01-01

Background To elucidate the relationship between safety culture maturity and safety performance of a particular company. Methods To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. Results The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. Conclusion The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance. PMID:25180135

Final safety analysis report for the Galileo Mission: Volume 2: Summary

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

The General Purpose Heat Source Radioisotope Thermoelectric Generator (GPHS-RTG) will be used as the prime source of electric power for the spacecraft on the Galileo mission. The use of radioactive material in these missions necessitates evaluations of the radiological risks that may be encountered by launch complex personnel and by the Earth's general population resulting from postulated malfunctions or failures occurring in the mission operations. The purpose of the Final Safety Analysis Report (FSAR) is to present the analyses and results of the latest evaluation of the nuclear safety potential of the GPHS-RTG as employed in the Galileo mission. Thismore » evaluation is an extension of earlier work that addressed the planned 1986 launch using the Space Shuttle Vehicle with the Centaur as the upper stage. This extended evaluation represents the launch by the Space Shuttle/IUS vehicle. The IUS stage has been selected as the vehicle to be used to boost the Galileo spacecraft into the Earth escape trajectory after the parking orbit is attained.« less

Safety and tolerability profile of daclizumab in patients with relapsing-remitting multiple sclerosis: An integrated analysis of clinical studies.

PubMed

Giovannoni, Gavin; Kappos, Ludwig; Gold, Ralf; Khatri, Bhupendra O; Selmaj, Krzysztof; Umans, Kimberly; Greenberg, Steven J; Sweetser, Marianne; Elkins, Jacob; McCroskery, Peter

2016-09-01

Daclizumab has been evaluated in multicentre, randomised, double-blind studies for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Safety and tolerability are key considerations in MS treatment selection, as they influence adherence to medication. Evaluate the safety of daclizumab in patients with RRMS from an integrated analysis of six clinical studies. Patients treated with at least one dose of subcutaneous daclizumab 150mg or 300mg monthly in three completed and three ongoing clinical studies were included in this integrated analysis. Cumulative incidence of treatment-emergent adverse events (AEs) was the primary endpoint. This analysis included 2236 patients with 5214 patient-years of exposure to daclizumab. The cumulative incidence of any AE was 84% and of any serious AE excluding MS relapse was 16%. The incidences of AEs when evaluated by 6-month intervals remained stable over the 6.5 years of maximum follow-up. Most AEs were mild or moderate in severity. An important safety concern associated with daclizumab therapy involved hepatic AEs (16%) and serum transaminase elevations at least three times the upper limit of normal (10%), most of which were asymptomatic, self-limiting, and non-recurring. Cumulative incidences of cutaneous, infectious, and gastrointestinal AEs were 33%, 59%, and 25%, respectively; most events either resolved spontaneously or were treated successfully with standard medical interventions and did not result in discontinuation of treatment. This integrated analysis demonstrates that treatment of RRMS with daclizumab for periods of up to 6.5 years is associated with an acceptable safety profile with no evidence of cumulative toxicity over time. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Simulation for Prediction of Entry Article Demise (SPEAD): An Analysis Tool for Spacecraft Safety Analysis and Ascent/Reentry Risk Assessment

NASA Technical Reports Server (NTRS)

Ling, Lisa

2014-01-01

For the purpose of performing safety analysis and risk assessment for a potential off-nominal atmospheric reentry resulting in vehicle breakup, a synthesis of trajectory propagation coupled with thermal analysis and the evaluation of node failure is required to predict the sequence of events, the timeline, and the progressive demise of spacecraft components. To provide this capability, the Simulation for Prediction of Entry Article Demise (SPEAD) analysis tool was developed. The software and methodology have been validated against actual flights, telemetry data, and validated software, and safety/risk analyses were performed for various programs using SPEAD. This report discusses the capabilities, modeling, validation, and application of the SPEAD analysis tool.

Safety assessment for EPS electron-proton spectrometer

NASA Technical Reports Server (NTRS)

Gleeson, P.

1971-01-01

A safety analysis was conducted to identify the efforts required to assure relatively hazard free operation of the EPS and to meet the safety requirements of the program. Safety engineering criteria, principles, and techniques in applicable disciplines are stressed in the performance of the system and subsystem studies; in test planning; in the design, development, test, evaluation, and checkout of the equipment; and the operating procedures for the EPS program.

High Reliability and the Evaluation of ATC System Configuration by Communizing Resources

NASA Astrophysics Data System (ADS)

Yamamoto, Masanori

Automatic Train Control (ATC) in the railway signalling system is required high safety, high availability, reduction of unit, energy saving and cost reduction. This paper described the resources communization redundancy of the ATC system that shared the redundant units in preparation for common use units in order to accommodate with this issue by keeping safety and availability in the same level of conventional ATC. It was evaluated on N+2 redundant system which established 2 spares for the common use system N piece in transmission division. It was done the safety evaluation of the N+2 redundant system by way of hazard analysis of FTA method and safety issue was confirmed by FMEA. The new redundant system concludes that 19% of downsizing and 36% of the energy saving are surely possible.

[Comprehensive evaluation of protective measures in electric welding].

PubMed

Ye, K; Zhao, Z

1995-03-01

Protective effects of safety masks, eyewear, work clothes, gloves, periodically physical examination system, and ventilation and barriers at workplace, were evaluated by one-way analysis for handtorch welding, carbon dioxide gas-protective welding, and argon-arc welding operations, etc. in township and village enterprises and state-owned enterprises by interviewing managers in the departments of technology and work safety and field investigating. Based on the results of one-way analysis of protective measures, comprehensive evaluations of various enterprises were made with a fussy mathematical model. Both enterprises in township and village level and of state-owned were graded as A on a basis of the evaluation, which will be helpful to the better management of occupational health in the future.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

PubMed

Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi

2018-03-01

Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.

Fire safety in transit systems fault tree analysis

DOT National Transportation Integrated Search

1981-09-01

Fire safety countermeasures applicable to transit vehicles are identified and evaluated. This document contains fault trees which illustrate the sequences of events which may lead to a transit-fire related casualty. A description of the basis for the...

CENTERLINE RUMBLE STRIPS SAFETY IMPACT EVALUATION—PHASE 2

DOT National Transportation Integrated Search

2018-02-02

Centerline rumble strips are used by various states as a low-cost countermeasure for mitigating cross-over crashes on two-way highways. This study performs a safety impact evaluation using an empirical Bayesian analysis. The researchers obtained a cr...

Meta-analysis of food safety training on hand hygiene knowledge and attitudes among food handlers.

PubMed

Soon, Jan Mei; Baines, Richard; Seaman, Phillip

2012-04-01

Research has shown that traditional food safety training programs and strategies to promote hand hygiene increases knowledge of the subject. However, very few studies have been conducted to evaluate the impact of food safety training on food handlers' attitudes about good hand hygiene practices. The objective of this meta-analytical study was to assess the extent to which food safety training or intervention strategies increased knowledge of and attitudes about hand hygiene. A systematic review of food safety training articles was conducted. Additional studies were identified from abstracts from food safety conferences and food science education conferences. Search terms included combinations of "food safety," "food hygiene," "training," "education," "hand washing," "hand hygiene," "knowledge," "attitudes," "practices," "behavior," and "food handlers." Only before- and after-training approaches and cohort studies with training (intervention group) and without training (control group) in hand hygiene knowledge and including attitudes in food handlers were evaluated. All pooled analyses were based on a random effects model. Meta-analysis values for nine food safety training and intervention studies on hand hygiene knowledge among food handlers were significantly higher than those of the control (without training), with an effect size (Hedges' g) of 1.284 (95% confidence interval [CI] ∼ 0.830 to 1.738). Meta-analysis of five food safety training and intervention studies in which hand hygiene attitudes and self-reported practices were monitored produced a summary effect size of 0.683 (95% CI ∼ 0.523 to 0.843). Food safety training increased knowledge and improved attitudes about hand hygiene practices. Refresher training and long-term reinforcement of good food handling behaviors may also be beneficial for sustaining good hand washing practices.

Endoscopic non-technical skills team training: the next step in quality assurance of endoscopy training.

PubMed

Matharoo, Manmeet; Haycock, Adam; Sevdalis, Nick; Thomas-Gibson, Siwan

2014-12-14

To investigate whether novel, non-technical skills training for Bowel Cancer Screening (BCS) endoscopy teams enhanced patient safety knowledge and attitudes. A novel endoscopy team training intervention for BCS teams was developed and evaluated as a pre-post intervention study. Four multi-disciplinary BCS teams constituting BCS endoscopist(s), specialist screening practitioners, endoscopy nurses and administrative staff (A) from English BCS training centres participated. No patients were involved in this study. Expert multidisciplinary faculty delivered a single day's training utilising real clinical examples. Pre and post-course evaluation comprised participants' patient safety awareness, attitudes, and knowledge. Global course evaluations were also collected. Twenty-three participants attended and their patient safety knowledge improved significantly from 43%-55% (P ≤ 0.001) following the training intervention. 12/41 (29%) of the safety attitudes items significantly improved in the areas of perceived patient safety knowledge and awareness. The remaining safety attitude items: perceived influence on patient safety, attitudes towards error management, error management actions and personal views following an error were unchanged following training. Both qualitative and quantitative global course evaluations were positive: 21/23 (91%) participants strongly agreed/agreed that they were satisfied with the course. Qualitative evaluation included mandating such training for endoscopy teams outside BCS and incorporating team training within wider endoscopy training. Limitations of the study include no measure of increased patient safety in clinical practice following training. A novel comprehensive training package addressing patient safety, non-technical skills and adverse event analysis was successful in improving multi-disciplinary teams' knowledge and safety attitudes.

Endoscopic non-technical skills team training: The next step in quality assurance of endoscopy training

PubMed Central

Matharoo, Manmeet; Haycock, Adam; Sevdalis, Nick; Thomas-Gibson, Siwan

2014-01-01

AIM: To investigate whether novel, non-technical skills training for Bowel Cancer Screening (BCS) endoscopy teams enhanced patient safety knowledge and attitudes. METHODS: A novel endoscopy team training intervention for BCS teams was developed and evaluated as a pre-post intervention study. Four multi-disciplinary BCS teams constituting BCS endoscopist(s), specialist screening practitioners, endoscopy nurses and administrative staff (A) from English BCS training centres participated. No patients were involved in this study. Expert multidisciplinary faculty delivered a single day’s training utilising real clinical examples. Pre and post-course evaluation comprised participants’ patient safety awareness, attitudes, and knowledge. Global course evaluations were also collected. RESULTS: Twenty-three participants attended and their patient safety knowledge improved significantly from 43%-55% (P ≤ 0.001) following the training intervention. 12/41 (29%) of the safety attitudes items significantly improved in the areas of perceived patient safety knowledge and awareness. The remaining safety attitude items: perceived influence on patient safety, attitudes towards error management, error management actions and personal views following an error were unchanged following training. Both qualitative and quantitative global course evaluations were positive: 21/23 (91%) participants strongly agreed/agreed that they were satisfied with the course. Qualitative evaluation included mandating such training for endoscopy teams outside BCS and incorporating team training within wider endoscopy training. Limitations of the study include no measure of increased patient safety in clinical practice following training. CONCLUSION: A novel comprehensive training package addressing patient safety, non-technical skills and adverse event analysis was successful in improving multi-disciplinary teams’ knowledge and safety attitudes. PMID:25516665

Preliminary hazards analysis -- vitrification process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Coordes, D.; Ruggieri, M.; Russell, J.

1994-06-01

This paper presents a Preliminary Hazards Analysis (PHA) for mixed waste vitrification by joule heating. The purpose of performing a PHA is to establish an initial hazard categorization for a DOE nuclear facility and to identify those processes and structures which may have an impact on or be important to safety. The PHA is typically performed during and provides input to project conceptual design. The PHA is then followed by a Preliminary Safety Analysis Report (PSAR) performed during Title 1 and 2 design. The PSAR then leads to performance of the Final Safety Analysis Report performed during the facility`s constructionmore » and testing. It should be completed before routine operation of the facility commences. This PHA addresses the first four chapters of the safety analysis process, in accordance with the requirements of DOE Safety Guidelines in SG 830.110. The hazards associated with vitrification processes are evaluated using standard safety analysis methods which include: identification of credible potential hazardous energy sources; identification of preventative features of the facility or system; identification of mitigative features; and analyses of credible hazards. Maximal facility inventories of radioactive and hazardous materials are postulated to evaluate worst case accident consequences. These inventories were based on DOE-STD-1027-92 guidance and the surrogate waste streams defined by Mayberry, et al. Radiological assessments indicate that a facility, depending on the radioactive material inventory, may be an exempt, Category 3, or Category 2 facility. The calculated impacts would result in no significant impact to offsite personnel or the environment. Hazardous materials assessment indicates that a Mixed Waste Vitrification facility will be a Low Hazard facility having minimal impacts to offsite personnel and the environment.« less

Systematic Analysis of Icotinib Treatment for Patients with Non-Small Cell Lung Cancer.

PubMed

Shi, Bing; Zhang, Xiu-Bing; Xu, Jian; Huang, Xin-En

2015-01-01

This analysis was conducted to evaluate the efficacy and safety of icotinib based regimens in treating patients with non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib-based regimens with regard to response and safety for patients with NSCLC were identified using a predefined search strategy. Pooled response rates of treatment were calculated. With icotinib-based regimens, 7 clinical studies which including 5,985 Chinese patients with NSCLC were considered eligible for inclusion. The pooled analysis suggested that, in all patients, the positive reponse rate was 30.1% (1,803/5,985) with icotinib-based regimens. Mild skin itching, rashes and diarrhea were the main side effects. No grade III or IV renal or liver toxicity was observed. No treatment-related death occurred in patients treated with icotinib-based regimens. This evidence based analysis suggests that icotinib based regimens are associated with mild response rate and acceptable toxicity for treating Chinese patients with NSCLC.

Bringing a transgenic crop to market: where compositional analysis fits.

PubMed

Privalle, Laura S; Gillikin, Nancy; Wandelt, Christine

2013-09-04

In the process of developing a biotechnology product, thousands of genes and transformation events are evaluated to select the event that will be commercialized. The ideal event is identified on the basis of multiple characteristics including trait efficacy, the molecular characteristics of the insert, and agronomic performance. Once selected, the commercial event is subjected to a rigorous safety evaluation taking a multipronged approach including examination of the safety of the gene and gene product - the protein, plant performance, impact of cultivating the crop on the environment, agronomic performance, and equivalence of the crop/food to conventional crops/food - by compositional analysis. The compositional analysis is composed of a comparison of the nutrient and antinutrient composition of the crop containing the event, its parental line (variety), and other conventional lines (varieties). Different geographies have different requirements for the compositional analysis studies. Parameters that vary include the number of years (seasons) and locations (environments) to be evaluated, the appropriate comparator(s), analytes to be evaluated, and statistical analysis. Specific examples of compositional analysis results will be presented.

Longitudinal safety evaluation of electric vehicles with the partial wireless charging lane on freeways.

PubMed

Li, Ye; Wang, Wei; Xing, Lu; Fan, Qi; Wang, Hao

2018-02-01

As an environment friendly transportation mode, the electric vehicle (EV) has drawn an increasing amount of attention from governments, vehicle manufactories and researchers recently. One of the biggest issue impeding EV's popularization associates with the charging process. The wireless charging lane (WCL) has been proposed as a convenient charging facility for EVs. Due to the high costs, the application of WCL on the entire freeways is impractical in the near future, while the partial WCL (PWCL) may be a feasible solution. This study aims to evaluate longitudinal safety of EVs with PWCL on freeways based on simulations. The simulation experiments are firstly designed, including deployment of PWCL on freeways and distribution of state of charge (SOC) of EVs. Then, a vehicle behavior model for EVs is proposed based on the intelligent driver model (IDM). Two surrogate safety measures, derived from time-to-collision (TTC), are utilized as indicators for safety evaluations. Sensitivity analysis is also conducted for related factors. Results show that the distribution of EVs' SOC significantly affect longitudinal safety when the PWCL is utilized. The low SOC in traffic consisting of EVs has the negative effect on longitudinal safety. The randomness and incompliance of EV drivers worsens the safety performance. The sensitivity analysis indicates that the larger maximum deceleration rate results in the higher longitudinal crash risks of EVs, while the length of PWCL has no monotonous effect. Different TTC thresholds also show no impact on results. A case study shows the consistent results. Based on the findings, several suggestions are discussed for EVs' safety improvement. Results of this study provide useful information for freeway safety when EVs are applied in the future. Copyright © 2017 Elsevier Ltd. All rights reserved.

Fire Safety of Passenger Trains : Phase II : Application of Fire Hazard Analysis Techniques

DOT National Transportation Integrated Search

2001-12-01

On May 12, 1999, the Federal Railroad Administration (FRA) issued regulations for passenger rail equipment safety standards that included small-scale fire tests and performance criteria to evaluate the flammability and smoke characteristics of indivi...

Fire safety of passenger trains. Phase II, Application of fire hazard analysis techniques.

DOT National Transportation Integrated Search

2001-12-01

On May 12, 1999, the Federal Railroad Administration (FRA) issued regulations for passenger rail equipment safety standards that included small-scale fire tests and performance criteria to evaluate the flammability and smoke characteristics of indivi...

Software for occupational health and safety risk analysis based on a fuzzy model.

PubMed

Stefanovic, Miladin; Tadic, Danijela; Djapan, Marko; Macuzic, Ivan

2012-01-01

Risk and safety management are very important issues in healthcare systems. Those are complex systems with many entities, hazards and uncertainties. In such an environment, it is very hard to introduce a system for evaluating and simulating significant hazards. In this paper, we analyzed different types of hazards in healthcare systems and we introduced a new fuzzy model for evaluating and ranking hazards. Finally, we presented a developed software solution, based on the suggested fuzzy model for evaluating and monitoring risk.

Reactor Safety Gap Evaluation of Accident Tolerant Components and Severe Accident Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Farmer, Mitchell T.; Bunt, R.; Corradini, M.

The overall objective of this study was to conduct a technology gap evaluation on accident tolerant components and severe accident analysis methodologies with the goal of identifying any data and/or knowledge gaps that may exist, given the current state of light water reactor (LWR) severe accident research, and additionally augmented by insights obtained from the Fukushima accident. The ultimate benefit of this activity is that the results can be used to refine the Department of Energy’s (DOE) Reactor Safety Technology (RST) research and development (R&D) program plan to address key knowledge gaps in severe accident phenomena and analyses that affectmore » reactor safety and that are not currently being addressed by the industry or the Nuclear Regulatory Commission (NRC).« less

Comparison of safety effect estimates obtained from empirical Bayes before-after study, propensity scores-potential outcomes framework, and regression model with cross-sectional data.

PubMed

Wood, Jonathan S; Donnell, Eric T; Porter, Richard J

2015-02-01

A variety of different study designs and analysis methods have been used to evaluate the performance of traffic safety countermeasures. The most common study designs and methods include observational before-after studies using the empirical Bayes method and cross-sectional studies using regression models. The propensity scores-potential outcomes framework has recently been proposed as an alternative traffic safety countermeasure evaluation method to address the challenges associated with selection biases that can be part of cross-sectional studies. Crash modification factors derived from the application of all three methods have not yet been compared. This paper compares the results of retrospective, observational evaluations of a traffic safety countermeasure using both before-after and cross-sectional study designs. The paper describes the strengths and limitations of each method, focusing primarily on how each addresses site selection bias, which is a common issue in observational safety studies. The Safety Edge paving technique, which seeks to mitigate crashes related to roadway departure events, is the countermeasure used in the present study to compare the alternative evaluation methods. The results indicated that all three methods yielded results that were consistent with each other and with previous research. The empirical Bayes results had the smallest standard errors. It is concluded that the propensity scores with potential outcomes framework is a viable alternative analysis method to the empirical Bayes before-after study. It should be considered whenever a before-after study is not possible or practical. Copyright © 2014 Elsevier Ltd. All rights reserved.

Development and Pilot Testing of a Food Safety Curriculum for Managers and Staff of Residential Childcare Institutions (RCCIs)

ERIC Educational Resources Information Center

Pivarnik, Lori F.; Patnoad, Martha S.; Nyachuba, David; McLandsborough, Lynne; Couto, Stephen; Hagan, Elsina E.; Breau, Marti

2013-01-01

Food safety training materials, targeted for residential childcare institution (RCCI) staff of facilities of 20 residents or less, were developed, piloted, and evaluated. The goal was to assist in the implementation of a Hazard Analysis Critical Control Points (HACCP)-based food safety plan as required by Food and Nutrition Service/United States…

FLAMMABLE GAS TECHNICAL BASIS DOCUMENT

DOE Office of Scientific and Technical Information (OSTI.GOV)

KRIPPS, L.J.

2005-02-18

This document describes the qualitative evaluation of frequency and consequences for double shell tank (DST) and single shell tank (SST) representative flammable gas accidents and associated hazardous conditions without controls. The evaluation indicated that safety-significant SSCs and/or TSRS were required to prevent or mitigate flammable gas accidents. Discussion on the resulting control decisions is included. This technical basis document was developed to support of the Tank Farms Documented Safety Analysis (DSA) and describes the risk binning process for the flammable gas representative accidents and associated represented hazardous conditions. The purpose of the risk binning process is to determine the needmore » for safety-significant structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls for a given representative accident or represented hazardous condition based on an evaluation of the event frequency and consequence.« less

Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

NASA Astrophysics Data System (ADS)

Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

2015-05-01

Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

Performance Analysis of the IEEE 802.11p Multichannel MAC Protocol in Vehicular Ad Hoc Networks

PubMed Central

2017-01-01

Vehicular Ad Hoc Networks (VANETs) employ multichannel to provide a variety of safety and non-safety applications, based on the IEEE 802.11p and IEEE 1609.4 protocols. The safety applications require timely and reliable transmissions, while the non-safety applications require efficient and high throughput. In the IEEE 1609.4 protocol, operating interval is divided into alternating Control Channel (CCH) interval and Service Channel (SCH) interval with an identical length. During the CCH interval, nodes transmit safety-related messages and control messages, and Enhanced Distributed Channel Access (EDCA) mechanism is employed to allow four Access Categories (ACs) within a station with different priorities according to their criticality for the vehicle’s safety. During the SCH interval, the non-safety massages are transmitted. An analytical model is proposed in this paper to evaluate performance, reliability and efficiency of the IEEE 802.11p and IEEE 1609.4 protocols. The proposed model improves the existing work by taking serval aspects and the character of multichannel switching into design consideration. Extensive performance evaluations based on analysis and simulation help to validate the accuracy of the proposed model and analyze the capabilities and limitations of the IEEE 802.11p and IEEE 1609.4 protocols, and enhancement suggestions are given. PMID:29231882

Performance Analysis of the IEEE 802.11p Multichannel MAC Protocol in Vehicular Ad Hoc Networks.

PubMed

Song, Caixia

2017-12-12

Vehicular Ad Hoc Networks (VANETs) employ multichannel to provide a variety of safety and non-safety applications, based on the IEEE 802.11p and IEEE 1609.4 protocols. The safety applications require timely and reliable transmissions, while the non-safety applications require efficient and high throughput. In the IEEE 1609.4 protocol, operating interval is divided into alternating Control Channel (CCH) interval and Service Channel (SCH) interval with an identical length. During the CCH interval, nodes transmit safety-related messages and control messages, and Enhanced Distributed Channel Access (EDCA) mechanism is employed to allow four Access Categories (ACs) within a station with different priorities according to their criticality for the vehicle's safety. During the SCH interval, the non-safety massages are transmitted. An analytical model is proposed in this paper to evaluate performance, reliability and efficiency of the IEEE 802.11p and IEEE 1609.4 protocols. The proposed model improves the existing work by taking serval aspects and the character of multichannel switching into design consideration. Extensive performance evaluations based on analysis and simulation help to validate the accuracy of the proposed model and analyze the capabilities and limitations of the IEEE 802.11p and IEEE 1609.4 protocols, and enhancement suggestions are given.

Further Analysis of Motorcycle Helmet Effectiveness Using CODES Linked Data

DOT National Transportation Integrated Search

1998-01-01

Linked data from the Crash Outcome Data Evaluation System (CODES) in seven : states was used by the National Highway Traffic Safety Administration as the : basis of a 1996 Report to Congress on the Benefits of Safety Belts and : Motorcycle Helmets (D...

2006 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

TenHaken, Ron; Daniels, B.; Becker, M.; Barnes, Zack; Donovan, Shawn; Manley, Brenda

2007-01-01

Throughout 2006, Range Safety was involved in a number of exciting and challenging activities and events, from developing, implementing, and supporting Range Safety policies and procedures-such as the Space Shuttle Launch and Landing Plans, the Range Safety Variance Process, and the Expendable Launch Vehicle Safety Program procedures-to evaluating new technologies. Range Safety training development is almost complete with the last course scheduled to go on line in mid-2007. Range Safety representatives took part in a number of panels and councils, including the newly formed Launch Constellation Range Safety Panel, the Range Commanders Council and its subgroups, the Space Shuttle Range Safety Panel, and the unmanned aircraft systems working group. Space based range safety demonstration and certification (formerly STARS) and the autonomous flight safety system were successfully tested. The enhanced flight termination system will be tested in early 2007 and the joint advanced range safety system mission analysis software tool is nearing operational status. New technologies being evaluated included a processor for real-time compensation in long range imaging, automated range surveillance using radio interferometry, and a space based range command and telemetry processor. Next year holds great promise as we continue ensuring safety while pursuing our quest beyond the Moon to Mars.

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Assessing the safety effects of cooperative intelligent transport systems: A bowtie analysis approach.

PubMed

Ehlers, Ute Christine; Ryeng, Eirin Olaussen; McCormack, Edward; Khan, Faisal; Ehlers, Sören

2017-02-01

The safety effects of cooperative intelligent transport systems (C-ITS) are mostly unknown and associated with uncertainties, because these systems represent emerging technology. This study proposes a bowtie analysis as a conceptual framework for evaluating the safety effect of cooperative intelligent transport systems. These seek to prevent road traffic accidents or mitigate their consequences. Under the assumption of the potential occurrence of a particular single vehicle accident, three case studies demonstrate the application of the bowtie analysis approach in road traffic safety. The approach utilizes exemplary expert estimates and knowledge from literature on the probability of the occurrence of accident risk factors and of the success of safety measures. Fuzzy set theory is applied to handle uncertainty in expert knowledge. Based on this approach, a useful tool is developed to estimate the effects of safety-related cooperative intelligent transport systems in terms of the expected change in accident occurrence and consequence probability. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of patient safety auditing in hospital care: results of a mixed-method evaluation (part 1).

PubMed

Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Westert, Gert P; Boeijen, Wilma; Teerenstra, Steven; van Gurp, Petra J; Wollersheim, Hub

2018-06-15

To evaluate the effectiveness of internal auditing in hospital care focussed on improving patient safety. A before-and-after mixed-method evaluation study was carried out in eight departments of a university medical center in the Netherlands. Internal auditing and feedback focussed on improving patient safety. The effect of internal auditing was assessed 15 months after the audit, using linear mixed models, on the patient, professional, team and departmental levels. The measurement methods were patient record review on adverse events (AEs), surveys regarding patient experiences, safety culture and team climate, analysis of administrative hospital data (standardized mortality rate, SMR) and safety walk rounds (SWRs) to observe frontline care processes on safety. The AE rate decreased from 36.1% to 31.3% and the preventable AE rate from 5.5% to 3.6%; however, the differences before and after auditing were not statistically significant. The patient-reported experience measures regarding patient safety improved slightly over time (P < 0.001). The SMR, patient safety culture and team climate remained unchanged after the internal audit. The SWRs showed that medication safety and information security were improved (P < 0.05). Internal auditing was associated with improved patient experiences and observed safety on wards. No effects were found on adverse outcomes, safety culture and team climate 15 months after the internal audit.

Analysis on Dangerous Source of Large Safety Accident in Storage Tank Area

NASA Astrophysics Data System (ADS)

Wang, Tong; Li, Ying; Xie, Tiansheng; Liu, Yu; Zhu, Xueyuan

2018-01-01

The difference between a large safety accident and a general accident is that the consequences of a large safety accident are particularly serious. To study the tank area which factors directly or indirectly lead to the occurrence of large-sized safety accidents. According to the three kinds of hazard source theory and the consequence cause analysis of the super safety accident, this paper analyzes the dangerous source of the super safety accident in the tank area from four aspects, such as energy source, large-sized safety accident reason, management missing, environmental impact Based on the analysis of three kinds of hazard sources and environmental analysis to derive the main risk factors and the AHP evaluation model is established, and after rigorous and scientific calculation, the weights of the related factors in four kinds of risk factors and each type of risk factors are obtained. The result of analytic hierarchy process shows that management reasons is the most important one, and then the environmental factors and the direct cause and Energy source. It should be noted that although the direct cause is relatively low overall importance, the direct cause of Failure of emergency measures and Failure of prevention and control facilities in greater weight.

Outcome Analysis Tool for Army Refractive Surgery Program

DTIC Science & Technology

2005-03-01

analysis function produces reports on the following information: " Evaluation of the safety of PRK and LASIK for maintenance of optimal visual...performance and ocular integrity. " Evaluation of the efficacy of PRK and LASIK by assessing the improvement in uncorrected vision for target detection...discrimination and recognition. "* Evaluation of the efficacy of PRK and LASIK by evaluating the stability of the refractive error over time

Preliminary Evaluation of an Aviation Safety Thesaurus' Utility for Enhancing Automated Processing of Incident Reports

NASA Technical Reports Server (NTRS)

Barrientos, Francesca; Castle, Joseph; McIntosh, Dawn; Srivastava, Ashok

2007-01-01

This document presents a preliminary evaluation the utility of the FAA Safety Analytics Thesaurus (SAT) utility in enhancing automated document processing applications under development at NASA Ames Research Center (ARC). Current development efforts at ARC are described, including overviews of the statistical machine learning techniques that have been investigated. An analysis of opportunities for applying thesaurus knowledge to improving algorithm performance is then presented.

Criticality Safety Evaluation of Standard Criticality Safety Requirements #1-520 g Operations in PF-4

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yamanaka, Alan Joseph Jr.

Guidance has been requested from the Nuclear Criticality Safety Division (NCSD) regarding processes that involve 520 grams of fissionable material or less. This Level-3 evaluation was conducted and documented in accordance with NCS-AP-004 (Ref. 1), formerly NCS-GUIDE-01. This evaluation is being written as a generic evaluation for all operations that will be able to operate using a 520-gram mass limit. Implementation for specific operations will be performed using a Level 1 CSED, which will confirm and document that this CSED can be used for the specific operation as discussed in NCS-MEMO-17-007 (Ref. 2). This Level 3 CSED updates and supersedesmore » the analysis performed in NCS-TECH-14-014 (Ref. 3).« less

Development and Validation of a Practical Instrument for Injury Prevention: The Occupational Safety and Health Monitoring and Assessment Tool (OSH-MAT).

PubMed

Sun, Yi; Arning, Martin; Bochmann, Frank; Börger, Jutta; Heitmann, Thomas

2018-06-01

The Occupational Safety and Health Monitoring and Assessment Tool (OSH-MAT) is a practical instrument that is currently used in the German woodworking and metalworking industries to monitor safety conditions at workplaces. The 12-item scoring system has three subscales rating technical, organizational, and personnel-related conditions in a company. Each item has a rating value ranging from 1 to 9, with higher values indicating higher standard of safety conditions. The reliability of this instrument was evaluated in a cross-sectional survey among 128 companies and its validity among 30,514 companies. The inter-rater reliability of the instrument was examined independently and simultaneously by two well-trained safety engineers. Agreement between the double ratings was quantified by the intraclass correlation coefficient and absolute agreement of the rating values. The content validity of the OSH-MAT was evaluated by quantifying the association between OSH-MAT values and 5-year average injury rates by Poisson regression analysis adjusted for the size of the companies and industrial sectors. The construct validity of OSH-MAT was examined by principle component factor analysis. Our analysis indicated good to very good inter-rater reliability (intraclass correlation coefficient = 0.64-0.74) of OSH-MAT values with an absolute agreement of between 72% and 81%. Factor analysis identified three component subscales that met exactly the structure theory of this instrument. The Poisson regression analysis demonstrated a statistically significant exposure-response relationship between OSH-MAT values and the 5-year average injury rates. These analyses indicate that OSH-MAT is a valid and reliable instrument that can be used effectively to monitor safety conditions at workplaces.

Sophisticated Calculation of the 1oo4-architecture for Safety-related Systems Conforming to IEC61508

NASA Astrophysics Data System (ADS)

Hayek, A.; Bokhaiti, M. Al; Schwarz, M. H.; Boercsoek, J.

2012-05-01

With the publication and enforcement of the standard IEC 61508 of safety related systems, recent system architectures have been presented and evaluated. Among a number of techniques and measures to the evaluation of safety integrity level (SIL) for safety-related systems, several measures such as reliability block diagrams and Markov models are used to analyze the probability of failure on demand (PFD) and mean time to failure (MTTF) which conform to IEC 61508. The current paper deals with the quantitative analysis of the novel 1oo4-architecture (one out of four) presented in recent work. Therefore sophisticated calculations for the required parameters are introduced. The provided 1oo4-architecture represents an advanced safety architecture based on on-chip redundancy, which is 3-failure safe. This means that at least one of the four channels have to work correctly in order to trigger the safety function.

Contribution of European research to risk analysis.

PubMed

Boenke, A

2001-12-01

The European Commission's, Quality of Life Research Programme, Key Action 1-Health, Food & Nutrition is mission-oriented and aims, amongst other things, at providing a healthy, safe and high-quality food supply leading to reinforced consumer confidence in the safety, of European food. Its objectives also include the enhancing of the competitiveness of the European food supply. Key Action 1 is currently supporting a number of different types of European collaborative projects in the area of risk analysis. The objectives of these projects range from the development and validation of prevention strategies including the reduction of consumers risks; development and validation of new modelling approaches, harmonization of risk assessment principles methodologies and terminology; standardization of methods and systems used for the safety evaluation of transgenic food; providing of tools for the evaluation of human viral contamination of shellfish and quality control; new methodologies for assessing the potential of unintended effects of genetically modified (genetically modified) foods; development of a risk assessment model for Cryptosporidium parvum related to the food and water industries, to the development of a communication platform for genetically modified organism, producers, retailers, regulatory authorities and consumer groups to improve safety assessment procedures, risk management strategies and risk communication; development and validation of new methods for safety testing of transgenic food; evaluation of the safety and efficacy of iron supplementation in pregnant women, evaluation of the potential cancer-preventing activity of pro- and pre-biotic ('synbiotic') combinations in human volunteers. An overview of these projects is presented here.

Probabilistic safety analysis of earth retaining structures during earthquakes

NASA Astrophysics Data System (ADS)

Grivas, D. A.; Souflis, C.

1982-07-01

A procedure is presented for determining the probability of failure of Earth retaining structures under static or seismic conditions. Four possible modes of failure (overturning, base sliding, bearing capacity, and overall sliding) are examined and their combined effect is evaluated with the aid of combinatorial analysis. The probability of failure is shown to be a more adequate measure of safety than the customary factor of safety. As Earth retaining structures may fail in four distinct modes, a system analysis can provide a single estimate for the possibility of failure. A Bayesian formulation of the safety retaining walls is found to provide an improved measure for the predicted probability of failure under seismic loading. The presented Bayesian analysis can account for the damage incurred to a retaining wall during an earthquake to provide an improved estimate for its probability of failure during future seismic events.

Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation.

PubMed

Saito, Masami; Iwasaki, Kiyotaka

2017-03-01

Our aim was to conduct a scoping review of the regulations for hemodialyzers in the safety evaluation in Japan and the United States, and to evaluate the criteria for premarketing clinical trials and postmarketing safety reports to inform the development of a sophisticated premarketing evaluation in Japan. Regulations for approval of hemodialyzers were identified from the databases of the Ministry of Health, Labor and Welfare in Japan and the Federal Drug Agency (FDA) in the United States (US). The criteria for premarket clinical trials and postmarketing safety reports were evaluated for both countries. Standards in Japan required evaluation of blood compatibility and reporting of acute adverse effects by a premarketing clinical trial in 6 of 86 applications with semipermeable membrane materials deemed to be different to those of previously approved devices from 1983 to 31 August 2015. By comparison, the clinical trial was required in one of 545 approvals in the US from 1976 to 29 January 2016, but blood compatibility was not the point. All postmarketing adverse effects identified in Japan were included in the set of 'warnings'. The more stringent requirements for evaluation of blood compatibility and acute adverse effects in Japan seemed to be related to differences in the history of quality management systems for medical devices between the two countries. This study revealed that there were differences between Japan and the US in requiring the premarketing clinical trials for the hemodialyzers. Our findings could be useful for constructing sophisticated premarketing safety evaluation.

Analysis of Industry Responses to Federal Regulations in Safety Requirements for New Automobiles

DOT National Transportation Integrated Search

1978-03-01

This report presents findings of an initial study of how the automobile industry has responded to the promulgation of motor vehicle standards by the U.S. goverment. The report examines three safety standards as evaluative cases: MVS 203--Steering col...

Evaluation of the Corridor Safety Improvement Program : phase 1 final report.

DOT National Transportation Integrated Search

1997-09-01

This project is an analysis of Oregon's Corridor Safety Improvement Programs implemented on Oregon Route 22 and Oregon Route 34. Improvements were : made along each corridor in 1993. : The project used a mail-out survey to determine the level of awar...

77 FR 49859 - Proposed Traffic Records Program Assessment Advisory

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-17

... States on the collection, management, and analysis of data used to inform highway and traffic safety... prioritize traffic safety issues and to choose appropriate countermeasures and evaluate their effectiveness. This document provides information on the contents, capabilities, and data quality attributes of an...

Use of evidential reasoning and AHP to assess regional industrial safety

PubMed Central

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China’s fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others. PMID:29795593

Use of evidential reasoning and AHP to assess regional industrial safety.

PubMed

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Yang, Zaili; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China's fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others.

NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

NASA Technical Reports Server (NTRS)

Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

2003-01-01

The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

Measuring Health Information Dissemination and Identifying Target Interest Communities on Twitter: Methods Development and Case Study of the @SafetyMD Network.

PubMed

Kandadai, Venk; Yang, Haodong; Jiang, Ling; Yang, Christopher C; Fleisher, Linda; Winston, Flaura Koplin

2016-05-05

Little is known about the ability of individual stakeholder groups to achieve health information dissemination goals through Twitter. This study aimed to develop and apply methods for the systematic evaluation and optimization of health information dissemination by stakeholders through Twitter. Tweet content from 1790 followers of @SafetyMD (July-November 2012) was examined. User emphasis, a new indicator of Twitter information dissemination, was defined and applied to retweets across two levels of retweeters originating from @SafetyMD. User interest clusters were identified based on principal component analysis (PCA) and hierarchical cluster analysis (HCA) of a random sample of 170 followers. User emphasis of keywords remained across levels but decreased by 9.5 percentage points. PCA and HCA identified 12 statistically unique clusters of followers within the @SafetyMD Twitter network. This study is one of the first to develop methods for use by stakeholders to evaluate and optimize their use of Twitter to disseminate health information. Our new methods provide preliminary evidence that individual stakeholders can evaluate the effectiveness of health information dissemination and create content-specific clusters for more specific targeted messaging.

Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus.

PubMed

Kahl, L; Patel, J; Layton, M; Binks, M; Hicks, K; Leon, G; Hachulla, E; Machado, D; Staumont-Sallé, D; Dickson, M; Condreay, L; Schifano, L; Zamuner, S; van Vollenhoven, R F

2016-11-01

We aimed to evaluate the pharmacodynamics, efficacy, safety and tolerability of the JAK1 inhibitor GSK2586184 in adults with systemic lupus erythematosus (SLE). In this adaptive, randomized, double-blind, placebo-controlled study, patients received oral GSK2586184 50-400 mg, or placebo twice daily for 12 weeks. Primary endpoints included interferon-mediated messenger RNA transcription over time, changes in Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index score, and number/severity of adverse events. A pre-specified interim analysis was performed when ≥ 5 patients per group completed 2 weeks of treatment. In total, 84-92% of patients were high baseline expressors of the interferon transcriptional biomarkers evaluated. At interim analysis, GSK2586184 showed no significant effect on mean interferon transcriptional biomarker expression (all panels). The study was declared futile and recruitment was halted at 50 patients. Shortly thereafter, significant safety data were identified, including elevated liver enzymes in six patients (one confirmed and one suspected case of Drug Reaction with Eosinophilia and Systemic Symptoms), leading to immediate dosing cessation. Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index scores were not analysed due to the small number of patients completing the study. The study futility and safety data described for GSK2586184 do not support further evaluation in patients with SLE. Study identifiers: GSK Study JAK115919; ClinicalTrials.gov identifier: NCT01777256.

Making safety an integral part of 5S in healthcare.

PubMed

Ikuma, Laura H; Nahmens, Isabelina

2014-01-01

Healthcare faces major challenges with provider safety and rising costs, and many organizations are using Lean to instigate change. One Lean tool, 5S, is becoming popular for improving efficiency of physical work environments, and it can also improve safety. This paper demonstrates that safety is an integral part of 5S by examining five specific 5S events in acute care facilities. We provide two arguments for how safety is linked to 5S:1. Safety is affected by 5S events, regardless of whether safety is a specific goal and 2. Safety can and should permeate all five S's as part of a comprehensive plan for system improvement. Reports of 5S events from five departments in one health system were used to evaluate how changes made at each step of the 5S impacted safety. Safety was affected positively in each step of the 5S through initial safety goals and side effects of other changes. The case studies show that 5S can be a mechanism for improving safety. Practitioners may reap additional safety benefits by incorporating safety into 5S events through a safety analysis before the 5S, safety goals and considerations during the 5S, and follow-up safety analysis.

Analysis of dynamical response of air blast loaded safety device

NASA Astrophysics Data System (ADS)

Tropkin, S. N.; Tlyasheva, R. R.; Bayazitov, M. I.; Kuzeev, I. R.

2018-03-01

Equipment of many oil and gas processing plants in the Russian Federation is considerably worn-out. This causes the decrease of reliability and durability of equipment and rises the accident rate. An air explosion is the one of the most dangerous cases for plants in oil and gas industry, usually caused by uncontrolled emission and inflammation of oil products. Air explosion can lead to significant danger for life and health of plant staff, so it necessitates safety device usage. A new type of a safety device is designed. Numerical simulation is necessary to analyse design parameters and performance of the safety device, subjected to air blast loading. Coupled fluid-structure interaction analysis is performed to determine strength of the protective device and its performance. The coupled Euler-Lagrange method, allowable in Abaqus by SIMULIA, is selected as the most appropriate analysis tool to study blast wave interaction with the safety device. Absorption factors of blast wave are evaluated for the safety device. This factors allow one to assess efficiency of the safety device, and its main structural component – dampener. Usage of CEL allowed one to model fast and accurately the dampener behaviour, and to develop the parametric model to determine safety device sizes.

Evaluation of pedestrian safety at intersections: A theoretical framework based on pedestrian-vehicle interaction patterns.

PubMed

Ni, Ying; Wang, Menglong; Sun, Jian; Li, Keping

2016-11-01

Pedestrians are the most vulnerable road users, and pedestrian safety has become a major research focus in recent years. Regarding the quality and quantity issues with collision data, conflict analysis using surrogate safety measures has become a useful method to study pedestrian safety. However, given the inequality between pedestrians and vehicles in encounters and the multiple interactions between pedestrians and vehicles, it is insufficient to simply use the same indicator(s) or the same way to aggregate indicators for all conditions. In addition, behavioral factors cannot be neglected. To better use information extracted from trajectories for safety evaluation and pay more attention on effects of behavioral factors, this paper develops a more sophisticated framework for pedestrian conflict analysis that takes pedestrian-vehicle interactions into consideration. A concept of three interaction patterns has been proposed for the first time, namely "hard interaction," "no interaction," and "soft-interaction." Interactions have been categorized under one of these patterns by analyzing profiles of speed and conflict indicators during the whole interactive processes. In this paper, a support vector machine (SVM) approach has been adopted to classify severity levels for a dataset including 1144 events extracted from three intersections in Shanghai, China, followed by an analysis of variable importance. The results revealed that different conflict indicators have different contributions to indicating the severity level under various interaction patterns. Therefore, it is recommended either to use specific conflict indicators or to use weighted indicator aggregation for each interaction pattern when evaluating pedestrian safety. The implementation has been carried out at the fourth crosswalk, and the results indicate that the proposed method can achieve a higher accuracy and better robustness than conventional methods. Furthermore, the method is helpful for better understanding underlying levels of safety from the behavioral perspective, which can also provide evidence for targeted traffic education on proper behaviors. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of the comfort and convenience of safety belt systems in 1980 and 1981 model vehicles

DOT National Transportation Integrated Search

1981-03-01

An analysis was conducted of both user and vehicle characteristics that influence the user perceptions of safety belt system comfort and convenience. A research design was developed involving various passenger cars, vans, and pickups, and a set of dr...

NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

2015-01-01

This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme.

PubMed

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-09-01

Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. The LUMINOUS programme comprises a prospective observational study assessing ranibizumab 'real-world' safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%). Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme

PubMed Central

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-01-01

Purpose Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. Methods The LUMINOUS programme comprises a prospective observational study assessing ranibizumab ‘real-world’ safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0–0.5%). Conclusions Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in ‘real-life’ settings. The 5-year LUMINOUS prospective observational study will address this need. PMID:23850682

Performance Evaluation and Analysis of Rural Drinking Water Safety Project——A Case Study in Jiangsu, China

NASA Astrophysics Data System (ADS)

Du, Xiaorong

2017-04-01

Water is the basic condition for human survival and development. As China is the most populous country, rural drinking water safety problems are most conspicuous. Therefore, the Chinese government keeps increasing investment and has built a large number of rural drinking water safety projects. Scientific evaluation of project performance is of great significance to promote the sustainable operation of the project and the sustainable development of rural economy. Previous studies mainly focus on the economic benefits of the project, while ignoring the fact that the rural drinking water safety project is quasi-public goods, which has economic, social and ecological benefits. This paper establishes a comprehensive evaluation model for rural drinking water safety performance, which adapts the rules of "5E" (economy, efficiency, effectiveness, equity and environment) as the value orientation, and selects a rural drinking water safety project as object in case study at K District, which is in the north of Jiangsu Province, China. The results shows: 1) the comprehensive performance of K project is in good condition; 2) The performance of every part shows that the scores of criteria "efficiency", "environment" and "effect" are higher than the mean performance, while the "economy" is slightly lower than the mean and the "equity" is the lowest. 3) The performance of indicator layer shows that: the planned completion rate of project, the reduction rate of project cost and the penetration rate of water-use population are significantly lower than other indicators. Based on the achievements of previous studies and the characteristics of rural drinking water safety project, this study integrates the evaluation dimensions of equity and environment, which can contribute to a more comprehensive and systematic assessment of project performance and provide empirical data for performance evaluation and management of rural drinking water safety project. Key Words: Rural drinking water safety project; Performance evaluation; 5E rules; Comprehensive evaluation model

Integrated optimisation technique based on computer-aided capacity and safety evaluation for managing downstream lane-drop merging area of signalised junctions

NASA Astrophysics Data System (ADS)

Chen, CHAI; Yiik Diew, WONG

2017-02-01

This study provides an integrated strategy, encompassing microscopic simulation, safety assessment, and multi-attribute decision-making, to optimize traffic performance at downstream merging area of signalized intersections. A Fuzzy Cellular Automata (FCA) model is developed to replicate microscopic movement and merging behavior. Based on simulation experiment, the proposed FCA approach is able to provide capacity and safety evaluation of different traffic scenarios. The results are then evaluated through data envelopment analysis (DEA) and analytic hierarchy process (AHP). Optimized geometric layout and control strategies are then suggested for various traffic conditions. An optimal lane-drop distance that is dependent on traffic volume and speed limit can thus be established at the downstream merging area.

An approach to evaluating reactive airborne wind shear systems

NASA Technical Reports Server (NTRS)

Gibson, Joseph P., Jr.

1992-01-01

An approach to evaluating reactive airborne windshear detection systems was developed to support a deployment study for future FAA ground-based windshear detection systems. The deployment study methodology assesses potential future safety enhancements beyond planned capabilities. The reactive airborne systems will be an integral part of planned windshear safety enhancements. The approach to evaluating reactive airborne systems involves separate analyses for both landing and take-off scenario. The analysis estimates the probability of effective warning considering several factors including NASA energy height loss characteristics, reactive alert timing, and a probability distribution for microburst strength.

A Pooled Analysis on Crizotinib in Treating Chinese Patients with EML4-ALK Positive Non-small-cell Lung Cancer.

PubMed

Li, Yang; Huang, Xin-En

2015-01-01

This analysis was conducted to evaluate the efficacy and safety of crizotinib based regimens in treating Chinese patients with EML4-ALK positive non-small-cell lung cancer. Clinical studies evaluating the efficacy and safety of crizotinib based regimens on response and safety for Chinese patients with EML4-ALK positive non-small-cell lung cancer were identified by using a predefined search strategy. Pooled response rate (RR) of treatment were calculated. In crizotinib based regimens, 3 clinical studies which including 128 Chinese patients with EML4-ALK positive non-small-cell lung cancer and treated with crizotinib based regimen were considered eligible for inclusion. Pooled analysis suggested that, in all patients, the pooled RR was 59.3% (76/128) in crizotinib based regimens. ALT/AST mild visual disturbances, nausea, and vomiting were the main side effects. No treatment related death occurred in these crizotinib based treatments. This pooled analysis suggests that crizotinib based regimens are associated with good response rate and accepted toxicities in treating Chinese patients with EML4-ALK positive non-small-cell lung cancer.

A Method for Evaluating the Safety Impacts of Air Traffic Automation

NASA Technical Reports Server (NTRS)

Kostiuk, Peter; Shapiro, Gerald; Hanson, Dave; Kolitz, Stephan; Leong, Frank; Rosch, Gene; Bonesteel, Charles

1998-01-01

This report describes a methodology for analyzing the safety and operational impacts of emerging air traffic technologies. The approach integrates traditional reliability models of the system infrastructure with models that analyze the environment within which the system operates, and models of how the system responds to different scenarios. Products of the analysis include safety measures such as predicted incident rates, predicted accident statistics, and false alarm rates; and operational availability data. The report demonstrates the methodology with an analysis of the operation of the Center-TRACON Automation System at Dallas-Fort Worth International Airport.

Evaluating the safety risk of roadside features for rural two-lane roads using reliability analysis.

PubMed

Jalayer, Mohammad; Zhou, Huaguo

2016-08-01

The severity of roadway departure crashes mainly depends on the roadside features, including the sideslope, fixed-object density, offset from fixed objects, and shoulder width. Common engineering countermeasures to improve roadside safety include: cross section improvements, hazard removal or modification, and delineation. It is not always feasible to maintain an object-free and smooth roadside clear zone as recommended in design guidelines. Currently, clear zone width and sideslope are used to determine roadside hazard ratings (RHRs) to quantify the roadside safety of rural two-lane roadways on a seven-point pictorial scale. Since these two variables are continuous and can be treated as random, probabilistic analysis can be applied as an alternative method to address existing uncertainties. Specifically, using reliability analysis, it is possible to quantify roadside safety levels by treating the clear zone width and sideslope as two continuous, rather than discrete, variables. The objective of this manuscript is to present a new approach for defining the reliability index for measuring roadside safety on rural two-lane roads. To evaluate the proposed approach, we gathered five years (2009-2013) of Illinois run-off-road (ROR) crash data and identified the roadside features (i.e., clear zone widths and sideslopes) of 4500 300ft roadway segments. Based on the obtained results, we confirm that reliability indices can serve as indicators to gauge safety levels, such that the greater the reliability index value, the lower the ROR crash rate. Copyright © 2016 Elsevier Ltd. All rights reserved.

Inductive Double-Contingency Analysis of UO2 Powder Bulk Blending Operations at a Commercial Fuel Plant (U)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Skiles, S. K.

1994-12-22

An inductive double-contingency analysis (DCA) method developed by the criticality safety function at the Savannah River Site, was applied in Criticality Safety Evaluations (CSEs) of five major plant process systems at the Westinghouse Electric Corporation`s Commercial Nuclear Fuel Manufacturing Plant in Columbia, South Carolina (WEC-Cola.). The method emphasizes a thorough evaluation of the controls intended to provide barriers against criticality for postulated initiating events, and has been demonstrated effective at identifying common mode failure potential and interdependence among multiple controls. A description of the method and an example of its application is provided.

System Vaccinology for the Evaluation of Influenza Vaccine Safety by Multiplex Gene Detection of Novel Biomarkers in a Preclinical Study and Batch Release Test

PubMed Central

Mizukami, Takuo; Momose, Haruka; Kuramitsu, Madoka; Takizawa, Kazuya; Araki, Kumiko; Furuhata, Keiko; Ishii, Ken J.; Hamaguchi, Isao; Yamaguchi, Kazunari

2014-01-01

Vaccines are beneficial and universal tools to prevent infectious disease. Thus, safety of vaccines is strictly evaluated in the preclinical phase of trials and every vaccine batch must be tested by the National Control Laboratories according to the guidelines published by each country. Despite many vaccine production platforms and methods, animal testing for safety evaluation is unchanged thus far. We recently developed a systems biological approach to vaccine safety evaluation where identification of specific biomarkers in a rat pre-clinical study evaluated the safety of vaccines for pandemic H5N1 influenza including Irf7, Lgals9, Lgalsbp3, Cxcl11, Timp1, Tap2, Psmb9, Psme1, Tapbp, C2, Csf1, Mx2, Zbp1, Ifrd1, Trafd1, Cxcl9, β2m, Npc1, Ngfr and Ifi47. The current study evaluated whether these 20 biomarkers could evaluate the safety, batch-to-batch and manufacturer-to-manufacturer consistency of seasonal trivalent influenza vaccine using a multiplex gene detection system. When we evaluated the influenza HA vaccine (HAv) from four different manufactures, the biomarker analysis correlated to findings from conventional animal use tests, such as abnormal toxicity test. In addition, sensitivity of toxicity detection and differences in HAvs were higher and more accurate than with conventional methods. Despite a slight decrease in body weight caused by HAv from manufacturer B that was not statistically significant, our results suggest that HAv from manufacturer B is significantly different than the other HAvs tested with regard to Lgals3bp, Tapbp, Lgals9, Irf7 and C2 gene expression in rat lungs. Using the biomarkers confirmed in this study, we predicted batch-to-batch consistency and safety of influenza vaccines within 2 days compared with the conventional safety test, which takes longer. These biomarkers will facilitate the future development of new influenza vaccines and provide an opportunity to develop in vitro methods of evaluating batch-to-batch consistency and vaccine safety as an alternative to animal testing. PMID:25010690

78 FR 70398 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... System Evaluation-Related Interview Data Collection. OMB Control Number: 2130-0574. Type of Request... approaches to improving safety, FRA has instituted the Confidential Close Call Reporting System (C\\3\\RS). The... reporting component, and a problem analysis/solution component. C\\3\\RS is expected to affect safety in two...

Response to in-depth safety audit of the L Lake sampling station

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gladden, J.B.

1986-10-15

An in-depth safety audit of several of the facilities and operations supporting the Biological Monitoring Program on L Lake was conducted. Subsequent to the initial audit, the audit team evaluated the handling of samples taken for analysis of Naegleria fowleri at the 704-U laboratory facility.

10 CFR 52.137 - Contents of applications; technical information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... limits on its operation, and presents a safety analysis of the structures, systems, and components and of... products. The description shall be sufficient to permit understanding of the system designs and their relationship to the safety evaluations. Items such as the reactor core, reactor coolant system, instrumentation...

Evaluation of radiological dispersion/consequence codes supporting DOE nuclear facility SARs

DOE Office of Scientific and Technical Information (OSTI.GOV)

O`Kula, K.R.; Paik, I.K.; Chung, D.Y.

1996-12-31

Since the early 1990s, the authorization basis documentation of many U.S. Department of Energy (DOE) nuclear facilities has been upgraded to comply with DOE orders and standards. In this process, many safety analyses have been revised. Unfortunately, there has been nonuniform application of software, and the most appropriate computer and engineering methodologies often are not applied. A DOE Accident Phenomenology and Consequence (APAC) Methodology Evaluation Program was originated at the request of DOE Defense Programs to evaluate the safety analysis methodologies used in nuclear facility authorization basis documentation and to define future cost-effective support and development initiatives. Six areas, includingmore » source term development (fire, spills, and explosion analysis), in-facility transport, and dispersion/ consequence analysis (chemical and radiological) are contained in the APAC program. The evaluation process, codes considered, key results, and recommendations for future model and software development of the Radiological Dispersion/Consequence Working Group are summarized in this paper.« less

Safety and reliability analysis in a polyvinyl chloride batch process using dynamic simulator-case study: Loss of containment incident.

PubMed

Rizal, Datu; Tani, Shinichi; Nishiyama, Kimitoshi; Suzuki, Kazuhiko

2006-10-11

In this paper, a novel methodology in batch plant safety and reliability analysis is proposed using a dynamic simulator. A batch process involving several safety objects (e.g. sensors, controller, valves, etc.) is activated during the operational stage. The performance of the safety objects is evaluated by the dynamic simulation and a fault propagation model is generated. By using the fault propagation model, an improved fault tree analysis (FTA) method using switching signal mode (SSM) is developed for estimating the probability of failures. The timely dependent failures can be considered as unavailability of safety objects that can cause the accidents in a plant. Finally, the rank of safety object is formulated as performance index (PI) and can be estimated using the importance measures. PI shows the prioritization of safety objects that should be investigated for safety improvement program in the plants. The output of this method can be used for optimal policy in safety object improvement and maintenance. The dynamic simulator was constructed using Visual Modeler (VM, the plant simulator, developed by Omega Simulation Corp., Japan). A case study is focused on the loss of containment (LOC) incident at polyvinyl chloride (PVC) batch process which is consumed the hazardous material, vinyl chloride monomer (VCM).

Evaluation of World Health Organization Multi-Professional Patient Safety Curriculum Topics in Nursing Education: Pre-test, post-test, none-experimental study.

PubMed

Mansour, Mansour; Skull, Alice; Parker, Michael

2015-01-01

The Multi-professional Patient Safety Curriculum Guide was launched by the World Health Organization to develop a patient safety-friendly curriculum in health education. The aim of this study was to evaluate the impact of teaching related to two topics from the Patient Safety Curriculum Guide on student nurses' knowledge and attitudes toward patient safety. A pretest, posttest, nonexperimental design was used. Patient safety education questionnaires were distributed to a convenience sample of 181 nursing students before the intervention, and 141 questionnaires after the intervention in one university in the East of England. The intervention consisted of two face-to-face lectures and one facilitated group work discussion. Seventy-one responses from pre- and posttest stages were matched. Paired t test, McNemar's test, and frequency measures were used for data analysis. The findings suggest that there are statistically significant differences in the subscales of the error and patient safety and personal influence over safety. The differences in the students' answers on patient safety knowledge before and after the interventions were not statistically significant. Although the student nurses highly commended the teaching delivered in this study, the use of experimental design in future curriculum evaluation may provide a more complementary insight to the findings of this study. Copyright © 2015 Elsevier Inc. All rights reserved.

VIPER: Chronic Pain after Amputation: Inflammatory Mechanisms, Novel Analgesic Pathways, and Improved Patient Safety

DTIC Science & Technology

2017-10-01

Through analysis of data obtained in the Molecular Signatures of Chronic Pain Subtypes study termed Veterans Integrated Pain Evaluation Research...immune cells (macrophages) to chronic pain while also evaluating novel analgesics in relevant animal models. The current proposal also attempts to...analysis of data obtained in the Molecular Signatures of Chronic Pain Subtypes study termed Veterans Integrated Pain Evaluation Research (VIPER

[Anaesthetic security: evolution of ideas].

PubMed

Cherif, Ali; Daghfous, Mounir; Saîdi, Yosri

2008-11-01

The concept of risk has not clear neither in the media nor in the medical field. It appears important to us to bring details relating some definitions in the field of anaesthesia safety. This work aims to clarify the concepts of safety, of risk in a medical activity like the Anaesthesia. A search was carried out on Medline with the following key words: Risk anaesthetic, anaesthetic Safety, anaesthetic mortality. The definitions of risk, of acceptable risk taking account of social and economic considerations are brought in this text. The ways to evaluate safety and the methods to achieve it was developed. The indicator of quality more used to evaluate safety is anaesthetic mortality. Many difficulties exist with the interpretation of data on mortality. The standards of care are normally established according to the degree of necessary safety. Concurrently to these standards exist certainly the human error which is a phenomenon towards which must direct all the efforts of improvement of safety but more especially the errors of system which are found regularly in the analysis of accidents and incident. The identification of the failures is the mandatory step to achieve safety.

Probabilistic design of fibre concrete structures

NASA Astrophysics Data System (ADS)

Pukl, R.; Novák, D.; Sajdlová, T.; Lehký, D.; Červenka, J.; Červenka, V.

2017-09-01

Advanced computer simulation is recently well-established methodology for evaluation of resistance of concrete engineering structures. The nonlinear finite element analysis enables to realistically predict structural damage, peak load, failure, post-peak response, development of cracks in concrete, yielding of reinforcement, concrete crushing or shear failure. The nonlinear material models can cover various types of concrete and reinforced concrete: ordinary concrete, plain or reinforced, without or with prestressing, fibre concrete, (ultra) high performance concrete, lightweight concrete, etc. Advanced material models taking into account fibre concrete properties such as shape of tensile softening branch, high toughness and ductility are described in the paper. Since the variability of the fibre concrete material properties is rather high, the probabilistic analysis seems to be the most appropriate format for structural design and evaluation of structural performance, reliability and safety. The presented combination of the nonlinear analysis with advanced probabilistic methods allows evaluation of structural safety characterized by failure probability or by reliability index respectively. Authors offer a methodology and computer tools for realistic safety assessment of concrete structures; the utilized approach is based on randomization of the nonlinear finite element analysis of the structural model. Uncertainty of the material properties or their randomness obtained from material tests are accounted in the random distribution. Furthermore, degradation of the reinforced concrete materials such as carbonation of concrete, corrosion of reinforcement, etc. can be accounted in order to analyze life-cycle structural performance and to enable prediction of the structural reliability and safety in time development. The results can serve as a rational basis for design of fibre concrete engineering structures based on advanced nonlinear computer analysis. The presented methodology is illustrated on results from two probabilistic studies with different types of concrete structures related to practical applications and made from various materials (with the parameters obtained from real material tests).

Safety analysis report for packaging, onsite, long-length contaminated equipment transport system

DOE Office of Scientific and Technical Information (OSTI.GOV)

McCormick, W.A.

1997-05-09

This safety analysis report for packaging describes the components of the long-length contaminated equipment (LLCE) transport system (TS) and provides the analyses, evaluations, and associated operational controls necessary for the safe use of the LLCE TS on the Hanford Site. The LLCE TS will provide a standardized, comprehensive approach for the disposal of approximately 98% of LLCE scheduled to be removed from the 200 Area waste tanks.

Visual analytics for aviation safety: A collaborative approach to sensemaking

NASA Astrophysics Data System (ADS)

Wade, Andrew

Visual analytics, the "science of analytical reasoning facilitated by interactive visual interfaces", is more than just visualization. Understanding the human reasoning process is essential for designing effective visualization tools and providing correct analyses. This thesis describes the evolution, application and evaluation of a new method for studying analytical reasoning that we have labeled paired analysis. Paired analysis combines subject matter experts (SMEs) and tool experts (TE) in an analytic dyad, here used to investigate aircraft maintenance and safety data. The method was developed and evaluated using interviews, pilot studies and analytic sessions during an internship at the Boeing Company. By enabling a collaborative approach to sensemaking that can be captured by researchers, paired analysis yielded rich data on human analytical reasoning that can be used to support analytic tool development and analyst training. Keywords: visual analytics, paired analysis, sensemaking, boeing, collaborative analysis.

Evaluation of the neighborhood environment walkability scale in Nigeria.

PubMed

Oyeyemi, Adewale L; Sallis, James F; Deforche, Benedicte; Oyeyemi, Adetoyeje Y; De Bourdeaudhuij, Ilse; Van Dyck, Delfien

2013-03-21

The development of reliable and culturally sensitive measures of attributes of the built and social environment is necessary for accurate analysis of environmental correlates of physical activity in low-income countries, that can inform international evidence-based policies and interventions in the worldwide prevention of physical inactivity epidemics. This study systematically adapted the Neighborhood Environment Walkability Scale (NEWS) for Nigeria and evaluated aspects of reliability and validity of the adapted version among Nigerian adults. The adaptation of the NEWS was conducted by African and international experts, and final items were selected for NEWS-Nigeria after a cross-validation of the confirmatory factor analysis structure of the original NEWS. Participants (N = 386; female = 47.2%) from two cities in Nigeria completed the adapted NEWS surveys regarding perceived residential density, land use mix - diversity, land use mix - access, street connectivity, infrastructure and safety for walking and cycling, aesthetics, traffic safety, and safety from crime. Self-reported activity for leisure, walking for different purposes, and overall physical activity were assessed with the validated International Physical Activity Questionnaire (long version). The adapted NEWS subscales had moderate to high test-retest reliability (ICC range 0.59 -0.91). Construct validity was good, with residents of high-walkable neighborhoods reporting significantly higher residential density, more land use mix diversity, higher street connectivity, more traffic safety and more safety from crime, but lower infrastructure and safety for walking/cycling and aesthetics than residents of low-walkable neighborhoods. Concurrent validity correlations were low to moderate (r = 0.10 -0.31) with residential density, land use mix diversity, and traffic safety significantly associated with most physical activity outcomes. The NEWS-Nigeria demonstrated acceptable measurement properties among Nigerian adults and may be useful for evaluation of the built environment in Nigeria. Further adaptation and evaluation in other African countries is needed to create a version that could be used throughout the African region.

Evaluation of the patient safety Leadership Walkabout programme of a hospital in Singapore.

PubMed

Lim, Raymond Boon Tar; Ng, Benjamin Boon Lui; Ng, Kok Mun

2014-02-01

The Patient Safety Leadership Walkabout (PSLWA) programme is a commonly employed tool in the West, in which senior leaders visit sites within the hospital that are involved in patient care to talk to healthcare staff about patient safety issues. As there is a lack of perspective regarding PSLWA in Asia, we carried out an evaluation of its effectiveness in improving the patient safety culture in Tan Tock Seng Hospital, Singapore. A mixed methods analysis approach was used to review and evaluate all documents, protocols, meeting minutes, post-walkabout surveys, action plans and verbal feedback pertaining to the walkabouts conducted from January 2005 to October 2012. A total of 321 patient safety issues were identified during the study period. Of these, 308 (96.0%) issues were resolved as of November 2012. Among the various categories of issues raised, issues related to work environment were the most common (45.2%). Of all the issues raised during the walkabouts, 72.9% were not identified through other conventional methods of error detection. With respect to the hospital's patient safety culture, 94.8% of the participants reported an increased awareness in patient safety and 90.2% expressed comfort in openly and honestly discussing patient safety issues. PSLWA serves as a good tool to uncover latent errors before actual harm reaches the patient. If properly implemented, it is an effective method for engaging leadership, identifying patient safety issues, and supporting a culture of patient safety in the hospital setting.

Perceived organizational support for safety and employee safety voice: the mediating role of coworker support for safety.

PubMed

Tucker, Sean; Chmiel, Nik; Turner, Nick; Hershcovis, M Sandy; Stride, Chris B

2008-10-01

In the present study, we modeled 2 sources of safety support (perceived organizational support for safety and perceived coworker support for safety) as predictors of employee safety voice, that is, speaking out in an attempt to change unsafe working conditions. Drawing on social exchange and social impact theories, we hypothesized and tested a mediated model predicting employee safety voice using a cross-sectional survey of urban bus drivers (n = 213) in the United Kingdom. Hierarchical regression analysis showed that perceived coworker support for safety fully mediated the relationship between perceived organizational support for safety and employee safety voice. This study adds to the employee voice literature by evaluating the important role that coworkers can play in encouraging others to speak out about safety issues. Implications for research and practice related to change-oriented safety communication are discussed.

Patient Reporting of Safety experiences in Organisational Care Transfers (PRoSOCT): a feasibility study of a patient reporting tool as a proactive approach to identifying latent conditions within healthcare systems

PubMed Central

Scott, Jason; Waring, Justin; Heavey, Emily; Dawson, Pamela

2014-01-01

Background It is increasingly recognised that patients can play a role in reporting safety incidents. Studies have tended to focus on patients within hospital settings, and on the reporting of patient safety incidents as defined within a medical model of safety. This study aims to determine the feasibility of collecting and using patient experiences of safety as a proactive approach to identifying latent conditions of safety as patients undergo organisational care transfers. Methods and analysis The study comprises three components: (1) patients’ experiences of safety relating to a care transfer, (2) patients’ receptiveness to reporting experiences of safety, (3) quality improvement using patient experiences of safety. (1) A safety survey and evaluation form will be distributed to patients discharged from 15 wards across four clinical areas (cardiac, care of older people, orthopaedics and stroke) over 1 year. Healthcare professionals involved in the care transfer will be provided with a regular summary of patient feedback. (2) Patients (n=36) who return an evaluation form will be sampled representatively based on the four clinical areas and interviewed about their experiences of healthcare and safety and completing the survey. (3) Healthcare professionals (n=75) will be invited to participate in semistructured interviews and focus groups to discuss their experiences with and perceptions of receiving and using patient feedback. Data analysis will explore the relationship between patient experiences of safety and other indicators and measures of quality and safety. Interview and focus group data will be thematically analysed and triangulated with all other data sources using a convergence coding matrix. Ethics and dissemination The study has been granted National Health Service (NHS) Research Ethics Committee approval. Patient experiences of safety will be disseminated to healthcare teams for the purpose of organisational development and quality improvement. Results will be disseminated to study participants as well as through peer-reviewed outputs. PMID:24833698

Improving the health and safety of 911 emergency call centre agents: an evaluability assessment of a knowledge transfer strategy.

PubMed

Dagenais, Christian; Plouffe, Laurence; Gagné, Charles; Toulouse, Georges; Breault, Andrée-Anne; Dupont, Didier

2017-03-01

A knowledge transfer (KT) strategy was implemented by the IRSST, an occupational health and safety research institute established in Québec (Canada), to improve the prevention of psychological and musculoskeletal problems among 911 emergency call centre agents. An evaluability assessment was conducted in which each aspect of the KT approach was documented systematically to determine whether the strategy had the potential to be evaluated in terms of its impact on the targeted population. A review of the literature on KT in occupational health and safety and on the evaluation of such KT programmes, along with the development of a logic model based on documentary analysis and semi-structured interviews with key stakeholders, indicated that the KT strategy was likely to have had a positive impact in the 911 emergency call centre sector. Implications for future research are discussed.

Methodology to assess clinical liver safety data.

PubMed

Merz, Michael; Lee, Kwan R; Kullak-Ublick, Gerd A; Brueckner, Andreas; Watkins, Paul B

2014-11-01

Analysis of liver safety data has to be multivariate by nature and needs to take into account time dependency of observations. Current standard tools for liver safety assessment such as summary tables, individual data listings, and narratives address these requirements to a limited extent only. Using graphics in the context of a systematic workflow including predefined graph templates is a valuable addition to standard instruments, helping to ensure completeness of evaluation, and supporting both hypothesis generation and testing. Employing graphical workflows interactively allows analysis in a team-based setting and facilitates identification of the most suitable graphics for publishing and regulatory reporting. Another important tool is statistical outlier detection, accounting for the fact that for assessment of Drug-Induced Liver Injury, identification and thorough evaluation of extreme values has much more relevance than measures of central tendency in the data. Taken together, systematical graphical data exploration and statistical outlier detection may have the potential to significantly improve assessment and interpretation of clinical liver safety data. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

Formal Foundations for Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2015-01-01

Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

Safety and Performance Analysis of the Non-Radar Oceanic/Remote Airspace In-Trail Procedure

NASA Technical Reports Server (NTRS)

Carreno, Victor A.; Munoz, Cesar A.

2007-01-01

This document presents a safety and performance analysis of the nominal case for the In-Trail Procedure (ITP) in a non-radar oceanic/remote airspace. The analysis estimates the risk of collision between the aircraft performing the ITP and a reference aircraft. The risk of collision is only estimated for the ITP maneuver and it is based on nominal operating conditions. The analysis does not consider human error, communication error conditions, or the normal risk of flight present in current operations. The hazards associated with human error and communication errors are evaluated in an Operational Hazards Analysis presented elsewhere.

Human performance cognitive-behavioral modeling: a benefit for occupational safety.

PubMed

Gore, Brian F

2002-01-01

Human Performance Modeling (HPM) is a computer-aided job analysis software methodology used to generate predictions of complex human-automation integration and system flow patterns with the goal of improving operator and system safety. The use of HPM tools has recently been increasing due to reductions in computational cost, augmentations in the tools' fidelity, and usefulness in the generated output. An examination of an Air Man-machine Integration Design and Analysis System (Air MIDAS) model evaluating complex human-automation integration currently underway at NASA Ames Research Center will highlight the importance to occupational safety of considering both cognitive and physical aspects of performance when researching human error.

Investment appraisal using quantitative risk analysis.

PubMed

Johansson, Henrik

2002-07-01

Investment appraisal concerned with investments in fire safety systems is discussed. Particular attention is directed at evaluating, in terms of the Bayesian decision theory, the risk reduction that investment in a fire safety system involves. It is shown how the monetary value of the change from a building design without any specific fire protection system to one including such a system can be estimated by use of quantitative risk analysis, the results of which are expressed in terms of a Risk-adjusted net present value. This represents the intrinsic monetary value of investing in the fire safety system. The method suggested is exemplified by a case study performed in an Avesta Sheffield factory.

Human performance cognitive-behavioral modeling: a benefit for occupational safety

NASA Technical Reports Server (NTRS)

Gore, Brian F.

2002-01-01

Human Performance Modeling (HPM) is a computer-aided job analysis software methodology used to generate predictions of complex human-automation integration and system flow patterns with the goal of improving operator and system safety. The use of HPM tools has recently been increasing due to reductions in computational cost, augmentations in the tools' fidelity, and usefulness in the generated output. An examination of an Air Man-machine Integration Design and Analysis System (Air MIDAS) model evaluating complex human-automation integration currently underway at NASA Ames Research Center will highlight the importance to occupational safety of considering both cognitive and physical aspects of performance when researching human error.

77 FR 32712 - Technical Report: Evaluation of the Enhancing Vehicle-to-Vehicle Crash Compatibility Agreement...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... information provided. FOR FURTHER INFORMATION CONTACT: Nathan K. Greenwell, Mathematical Statistician, Evaluation Division, NVS-431, National Center for Statistics and Analysis, National Highway Traffic Safety... you to send a copy to Nathan K. Greenwell, Mathematical Statistician, Evaluation Division, NVS-431...

Development and evaluation of a web-based software for crash data collection, processing and analysis.

PubMed

Montella, Alfonso; Chiaradonna, Salvatore; Criscuolo, Giorgio; De Martino, Salvatore

2017-02-05

First step of the development of an effective safety management system is to create reliable crash databases since the quality of decision making in road safety depends on the quality of the data on which decisions are based. Improving crash data is a worldwide priority, as highlighted in the Global Plan for the Decade of Action for Road Safety adopted by the United Nations, which recognizes that the overall goal of the plan will be attained improving the quality of data collection at the national, regional and global levels. Crash databases provide the basic information for effective highway safety efforts at any level of government, but lack of uniformity among countries and among the different jurisdictions in the same country is observed. Several existing databases show significant drawbacks which hinder their effective use for safety analysis and improvement. Furthermore, modern technologies offer great potential for significant improvements of existing methods and procedures for crash data collection, processing and analysis. To address these issues, in this paper we present the development and evaluation of a web-based platform-independent software for crash data collection, processing and analysis. The software is designed for mobile and desktop electronic devices and enables a guided and automated drafting of the crash report, assisting police officers both on-site and in the office. The software development was based both on the detailed critical review of existing Australasian, EU, and U.S. crash databases and software as well as on the continuous consultation with the stakeholders. The evaluation was carried out comparing the completeness, timeliness, and accuracy of crash data before and after the use of the software in the city of Vico Equense, in south of Italy showing significant advantages. The amount of collected information increased from 82 variables to 268 variables, i.e., a 227% increase. The time saving was more than one hour per crash, i.e., a 36% reduction. The on-site data collection did not produce time saving, however this is a temporary weakness that will be annihilated very soon in the future after officers are more acquainted with the software. The phase of evaluation, processing and analysis carried out in the office was dramatically shortened, i.e., a 69% reduction. Another benefit was the standardization which allowed fast and consistent data analysis and evaluation. Even if all these benefits are remarkable, the most valuable benefit of the new procedure was the reduction of the police officers mistakes during the manual operations of survey and data evaluation. Because of these benefits, the satisfaction questionnaires administrated to the police officers after the testing phase showed very good acceptance of the procedure. Copyright © 2017 Elsevier Ltd. All rights reserved.

Selecting an Architecture for a Safety-Critical Distributed Computer System with Power, Weight and Cost Considerations

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2014-01-01

This report presents an example of the application of multi-criteria decision analysis to the selection of an architecture for a safety-critical distributed computer system. The design problem includes constraints on minimum system availability and integrity, and the decision is based on the optimal balance of power, weight and cost. The analysis process includes the generation of alternative architectures, evaluation of individual decision criteria, and the selection of an alternative based on overall value. In this example presented here, iterative application of the quantitative evaluation process made it possible to deliberately generate an alternative architecture that is superior to all others regardless of the relative importance of cost.

Safety Issues with Hydrogen as a Vehicle Fuel

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cadwallader, Lee Charles; Herring, James Stephen

1999-10-01

This report is an initial effort to identify and evaluate safety issues associated with the use of hydrogen as a vehicle fuel in automobiles. Several forms of hydrogen have been considered: gas, liquid, slush, and hydrides. The safety issues have been discussed, beginning with properties of hydrogen and the phenomenology of hydrogen combustion. Safety-related operating experiences with hydrogen vehicles have been summarized to identify concerns that must be addressed in future design activities and to support probabilistic risk assessment. Also, applicable codes, standards, and regulations pertaining to hydrogen usage and refueling have been identified and are briefly discussed. This reportmore » serves as a safety foundation for any future hydrogen safety work, such as a safety analysis or a probabilistic risk assessment.« less

Safety Issues with Hydrogen as a Vehicle Fuel

DOE Office of Scientific and Technical Information (OSTI.GOV)

L. C. Cadwallader; J. S. Herring

1999-09-01

This report is an initial effort to identify and evaluate safety issues associated with the use of hydrogen as a vehicle fuel in automobiles. Several forms of hydrogen have been considered: gas, liquid, slush, and hydrides. The safety issues have been discussed, beginning with properties of hydrogen and the phenomenology of hydrogen combustion. Safety-related operating experiences with hydrogen vehicles have been summarized to identify concerns that must be addressed in future design activities and to support probabilistic risk assessment. Also, applicable codes, standards, and regulations pertaining to hydrogen usage and refueling have been identified and are briefly discussed. This reportmore » serves as a safety foundation for any future hydrogen safety work, such as a safety analysis or a probabilistic risk assessment.« less

On Building an Ontological Knowledge Base for Managing Patient Safety Events.

PubMed

Liang, Chen; Gong, Yang

2015-01-01

Over the past decade, improving healthcare quality and safety through patient safety event reporting systems has drawn much attention. Unfortunately, such systems are suffering from low data quality, inefficient data entry and ineffective information retrieval. For improving the systems, we develop a semantic web ontology based on the WHO International Classification for Patient Safety (ICPS) and AHRQ Common Formats for patient safety event reporting. The ontology holds potential in enhancing knowledge management and information retrieval, as well as providing flexible data entry and case analysis for both reporters and reviewers of patient safety events. In this paper, we detailed our efforts in data acquisition, transformation, implementation and initial evaluation of the ontology.

Road safety risk evaluation and target setting using data envelopment analysis and its extensions.

PubMed

Shen, Yongjun; Hermans, Elke; Brijs, Tom; Wets, Geert; Vanhoof, Koen

2012-09-01

Currently, comparison between countries in terms of their road safety performance is widely conducted in order to better understand one's own safety situation and to learn from those best-performing countries by indicating practical targets and formulating action programmes. In this respect, crash data such as the number of road fatalities and casualties are mostly investigated. However, the absolute numbers are not directly comparable between countries. Therefore, the concept of risk, which is defined as the ratio of road safety outcomes and some measure of exposure (e.g., the population size, the number of registered vehicles, or distance travelled), is often used in the context of benchmarking. Nevertheless, these risk indicators are not consistent in most cases. In other words, countries may have different evaluation results or ranking positions using different exposure information. In this study, data envelopment analysis (DEA) as a performance measurement technique is investigated to provide an overall perspective on a country's road safety situation, and further assess whether the road safety outcomes registered in a country correspond to the numbers that can be expected based on the level of exposure. In doing so, three model extensions are considered, which are the DEA based road safety model (DEA-RS), the cross-efficiency method, and the categorical DEA model. Using the measures of exposure to risk as the model's input and the number of road fatalities as output, an overall road safety efficiency score is computed for the 27 European Union (EU) countries based on the DEA-RS model, and the ranking of countries in accordance with their cross-efficiency scores is evaluated. Furthermore, after applying clustering analysis to group countries with inherent similarity in their practices, the categorical DEA-RS model is adopted to identify best-performing and underperforming countries in each cluster, as well as the reference sets or benchmarks for those underperforming ones. More importantly, the extent to which each reference set could be learned from is specified, and practical yet challenging targets are given for each underperforming country, which enables policymakers to recognize the gap with those best-performing countries and further develop their own road safety policy. Copyright © 2012 Elsevier Ltd. All rights reserved.

Evaluating oversight systems for emerging technologies: a case study of genetically engineered organisms.

PubMed

Kuzma, Jennifer; Najmaie, Pouya; Larson, Joel

2009-01-01

The U.S. oversight system for genetically engineered organisms (GEOs) was evaluated to develop hypotheses and derive lessons for oversight of other emerging technologies, such as nanotechnology. Evaluation was based upon quantitative expert elicitation, semi-standardized interviews, and historical literature analysis. Through an interdisciplinary policy analysis approach, blending legal, ethical, risk analysis, and policy sciences viewpoints, criteria were used to identify strengths and weaknesses of GEOs oversight and explore correlations among its attributes and outcomes. From the three sources of data, hypotheses and broader conclusions for oversight were developed. Our analysis suggests several lessons for oversight of emerging technologies: the importance of reducing complexity and uncertainty in oversight for minimizing financial burdens on small product developers; consolidating multi-agency jurisdictions to avoid gaps and redundancies in safety reviews; consumer benefits for advancing acceptance of GEO products; rigorous and independent pre- and post-market assessment for environmental safety; early public input and transparency for ensuring public confidence; and the positive role of public input in system development, informed consent, capacity, compliance, incentives, and data requirements and stringency in promoting health and environmental safety outcomes, as well as the equitable distribution of health impacts. Our integrated approach is instructive for more comprehensive analyses of oversight systems, developing hypotheses for how features of oversight systems affect outcomes, and formulating policy options for oversight of future technological products, especially nanotechnology products.

[Associations of occupational safety atmosphere and behaviors with unintentional injuries].

PubMed

Xiao, Ya-ni; Huang, Zhi-xiong; Huang, Shao-bin; Cao, Xiao-ou; Chen, Xia-ming; Liu, Xu-hua; Chen, Wei-qing

2012-07-01

To evaluate the associations of perception of safety atmosphere at workplace, occupational safety attitude and behaviors with occupational unintentional injury among manufacturing workers. A cross-sectional study was performed and a self-administered questionnaire was used to inquire socio-demographic characteristics, perceived safety atmosphere, occupational safety attitudes, occupational safety behaviors and occupational unintentional injuries among 10585 manufacturing workers selected from 46 enterprises in Guangdong. Structural equation modeling was applied to assess the relationship of the perception of safety atmosphere at workplace, occupational safety attitude, and occupational safety behaviors with occupational unintentional injury. Among 24 pathways supposed in structural equation model, 20 pathways (except for the attitude toward occupational safety, the attitude toward managers' support, the work posture and individual protection) were significantly related to the occupational unintentional injuries. The further analysis indicated that the perceived safety atmosphere might impact the occupational unintentional injuries by the attitude toward occupational safety and occupational safety behaviors. Workers' perception of safety atmosphere indirectly influenced on occupational unintentional injuries through occupational safety attitudes and occupational safety behaviors.

Response Time Analysis and Test of Protection System Instrument Channels for APR1400 and OPR1000

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Chang Jae; Han, Seung; Yun, Jae Hee

2015-07-01

Safety limits are required to maintain the integrity of physical barriers designed to prevent the uncontrolled release of radioactive materials in nuclear power plants. The safety analysis establishes two critical constraints that include an analytical limit in terms of a measured or calculated variable, and a specific time after the analytical limit is reached to begin protective action. Keeping with the nuclear regulations and industry standards, satisfying these two requirements will ensure that the safety limit will not be exceeded during the design basis event, either an anticipated operational occurrence or a postulated accident. Various studies on the setpoint determinationmore » methodology for the safety-related instrumentation have been actively performed to ensure that the requirement of the analytical limit is satisfied. In particular, the protection setpoint methodology for the advanced power reactor 1400 (APP1400) and the optimized power reactor 1000 (OPR1000) has been recently developed to cover both the design basis event and the beyond design basis event. The developed setpoint methodology has also been quantitatively validated using specific computer programs and setpoint calculations. However, the safety of nuclear power plants cannot be fully guaranteed by satisfying the requirement of the analytical limit. In spite of the response time verification requirements of nuclear regulations and industry standards, it is hard to find the studies on the systematically integrated methodology regarding the response time evaluation. In cases of APR1400 and OPR1000, the response time analysis for the plant protection system is partially included in the setpoint calculation and the response time test is separately performed via the specific plant procedure. The test technique has a drawback which is the difficulty to demonstrate completeness of timing test. The analysis technique has also a demerit of resulting in extreme times that not actually possible. Thus, the establishment of the systematic response time evaluation methodology is needed to justify the conformance to the response time requirement used in the safety analysis. This paper proposes the response time evaluation methodology for APR1400 and OPR1000 using the combined analysis and test technique to confirm that the plant protection system can meet the analytical response time assumed in the safety analysis. In addition, the results of the quantitative evaluation performed for APR1400 and OPR1000 are presented in this paper. The proposed response time analysis technique consists of defining the response time requirement, determining the critical signal path for the trip parameter, allocating individual response time to each component on the signal path, and analyzing the total response time for the trip parameter, and demonstrates that the total analyzed response time does not exceed the response time requirement. The proposed response time test technique is composed of defining the response time requirement, determining the critical signal path for the trip parameter, determining the test method for each component on the signal path, performing the response time test, and demonstrates that the total test result does not exceed the response time requirement. The total response time should be tested in a single test that covers from the sensor to the final actuation device on the instrument channel. When the total channel is not tested in a single test, separate tests on groups of components or single components including the total instrument channel shall be combined to verify the total channel response. For APR1400 and OPR1000, the ramp test technique is used for the pressure and differential pressure transmitters and the step function testing technique is applied to the signal processing equipment and final actuation device. As a result, it can be demonstrated that the response time requirement is satisfied by the combined analysis and test technique. Therefore, the proposed methodology in this paper plays a crucial role in guaranteeing the safety of the nuclear power plants systematically satisfying one of two critical requirements from the safety analysis. (authors)« less

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance.

PubMed

Izem, Rima; Sanchez-Kam, Matilde; Ma, Haijun; Zink, Richard; Zhao, Yueqin

2018-03-01

Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. This paper discusses data sources and analysis considerations for safety signal detection after a medical product is approved for marketing. This manuscript is the second in a series of papers from the American Statistical Association Biopharmaceutical Section Safety Working Group. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from passive postmarketing surveillance systems compared to other sources. Signal detection has traditionally relied on spontaneous reporting databases that have been available worldwide for decades. However, current regulatory guidelines and ease of reporting have increased the size of these databases exponentially over the last few years. With such large databases, data-mining tools using disproportionality analysis and helpful graphics are often used to detect potential signals. Although the data sources have many limitations, analyses of these data have been successful at identifying safety signals postmarketing. Experience analyzing these dynamic data is useful in understanding the potential and limitations of analyses with new data sources such as social media, claims, or electronic medical records data.

Perceptions of sexual partner safety.

PubMed

Masaro, C L; Dahinten, V S; Johnson, J; Ogilvie, G; Patrick, D M

2008-06-01

Many individuals select sexual partners based on assumed partner STI/HIV safety, yet few studies have investigated how these assumptions are formed. The objective of this research was to determine the extent to which partner safety beliefs were used to evaluate partner safety, and whether these beliefs influenced perceptions of personal STI/HIV risk. Participants (n = 317) recruited from an STI clinic completed a structured self-report questionnaire. A Partner Safety Beliefs Scale (PSBS) was developed to determine the factors that most influenced perceived partner safety. Exploratory factor analysis showed that a single factor accounted for 46% of the variance in the PSBS; with an internal consistency of 0.92. Linear regression was used to determine factors predictive of perceived personal STI/HIV risk. Participants endorsed statements indicating that knowing or trusting a sexual partner influences their beliefs about their partner's safety. Linear regression analysis indicated that education, income, number of sexual partners, and PSBS scores were significant predictors of perceived personal STI/HIV risk. The results of this study indicate that many individuals are relying on partner attributes and relationship characteristics when assessing the STI/HIV status of a sexual partner, and that this reliance is associated with a decreased perception of personal STI/HIV risk. Prevention campaigns need to acknowledge that people are likely to evaluate sexual partners whom they know and trust as safe. Dispelling erroneous beliefs about the ability to select safe partners is needed to promote safer sexual behavior.

Patient safety culture in obstetrics and gynecology and neonatology units: the nurses' and the midwives' opinion.

PubMed

Ribeliene, Janina; Blazeviciene, Aurelija; Nadisauskiene, Ruta Jolanta; Tameliene, Rasa; Kudreviciene, Ausrele; Nedzelskiene, Irena; Macijauskiene, Jurate

2018-04-22

Patients treated in health care facilities that provide services in the fields of obstetrics, gynecology, and neonatology are especially vulnerable. Large multidisciplinary teams of physicians, multiple invasive and noninvasive diagnostic and therapeutic procedures, and the use of advanced technologies increase the probability of adverse events. The evaluation of knowledge about patient safety culture among nurses and midwives working in such units and the identification of critical areas at a health care institution would reduce the number of adverse events and improve patient safety. The aim of the study was to evaluate the opinion of nurses and midwives working in clinical departments that provide services in the fields of obstetrics, gynecology, and neonatology about patient safety culture and to explore potential predictors for the overall perception of safety. We used the Hospital Survey on Patient Safety Culture (HSOPSC) to evaluate nurses' and midwives' opinion about patient safety issues. The overall response rate in the survey was 100% (n = 233). The analysis of the dimensions of safety on the unit level showed that the respondents' most positive evaluations were in the Organizational Learning - Continuous Improvement (73.2%) and Feedback and Communication about Error (66.8%) dimensions, and the most negative evaluations in the Non-punitive Response to Error (33.5%) and Staffing (44.6%) dimensions. On the hospital level, the evaluation of the safety dimensions ranged between 41.4 and 56.8%. The percentage of positive responses in the outcome dimensions Frequency of Events Reported was 82.4%. We found a significant association between the outcome dimension Frequency of Events Reported and the Hospital Management Support for Patient Safety and Feedback and Communication about Error Dimensions. On the hospital level, the critical domains in health care facilities that provide services in the fields of obstetrics, gynecology, and neonatology were Teamwork Across Hospital Units, and on the unit level - Communication Openness, Teamwork Within Units, Non-punitive Response to Error, and Staffing. The remaining domains were seen as having a potential for improvement.

SER assistant: An expert system for safety evaluation reports

DOE Office of Scientific and Technical Information (OSTI.GOV)

DeChaine, M.D.; Levine, S.H.; Feltus, M.A.

1993-01-01

The SER Assistant is an expert system that assists engineers to write safety evaluation reports (SERs). Section 50.59 of the Code of Federal Regulations allows modifications to be made to nuclear power plants without prior US Nuclear Regulatory Commission approval if two conditions are satisfied. First, the change must not affect the technical specifications of the plant. Second, the modification must not affect a part of the plant described in the final safety analysis report, or if it does, it must not create an unreviewed safety question. The purpose of an SER is to ensure that these conditions are satisfiedmore » for the proposed modification. The SER Assistant aids this process by providing relevant, but directed, questions and information as well as giving engineers an organized environment to document their thought processes.« less

Evaluation of the safety of mobile units for the conditioning of radioactive waste

DOE Office of Scientific and Technical Information (OSTI.GOV)

Filss, Martin; Wallner, Christian

2013-07-01

In Germany mobile units are used to treat and condition radioactive waste. On behalf of the relevant authorities TUV SUD Industrie Service GmbH evaluates their safety. In this paper we outline the general procedure we apply and point out typical results. Generally, a generic safety case evaluates the effects of incidents and accidents and its consequences for the workers and the public. Special care is necessary to define the radioactive inventory, the nuclide composition and the mobility of the radioactive substances. A systems analysis is carried out. Typical aspects to be considered are the handling procedures, the measurement devices andmore » automatic actions. From the various possible malfunctions the critical ones have to be identified. Generally one or only a few scenarios have to be considered in detail. (authors)« less

Data Analysis Approaches for the Risk-Informed Safety Margins Characterization Toolkit

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mandelli, Diego; Alfonsi, Andrea; Maljovec, Daniel P.

2016-09-01

In the past decades, several numerical simulation codes have been employed to simulate accident dynamics (e.g., RELAP5-3D, RELAP-7, MELCOR, MAAP). In order to evaluate the impact of uncertainties into accident dynamics, several stochastic methodologies have been coupled with these codes. These stochastic methods range from classical Monte-Carlo and Latin Hypercube sampling to stochastic polynomial methods. Similar approaches have been introduced into the risk and safety community where stochastic methods (such as RAVEN, ADAPT, MCDET, ADS) have been coupled with safety analysis codes in order to evaluate the safety impact of timing and sequencing of events. These approaches are usually calledmore » Dynamic PRA or simulation-based PRA methods. These uncertainties and safety methods usually generate a large number of simulation runs (database storage may be on the order of gigabytes or higher). The scope of this paper is to present a broad overview of methods and algorithms that can be used to analyze and extract information from large data sets containing time dependent data. In this context, “extracting information” means constructing input-output correlations, finding commonalities, and identifying outliers. Some of the algorithms presented here have been developed or are under development within the RAVEN statistical framework.« less

75 FR 4822 - Decision To Evaluate a Petition To Designate a Class of Employees for Linde Ceramics, Tonawanda...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-29

... evaluation, is as follows: Facility: Linde Ceramics. Location: Tonawanda, New York. Job Titles and/or Job... Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway...

75 FR 27783 - Decision To Evaluate a Petition To Designate a Class of Employees From the Mound Site in...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... evaluation, is as follows: Facility: Mound site. Location: Miamisburg, Ohio. Job Titles and/or Job Duties... Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway...

Evaluation of adaptive signal control technology--volume 1 : before-conditions data collection and analysis.

DOT National Transportation Integrated Search

2017-04-01

Field evaluation of adaptive signal control technologies (ASCT) is very important in understanding the systems contribution to safety : and operational efficiency. Data were collected at six intersections along the Neil Street corridor in Champaig...

An application of multiattribute decision analysis to the Space Station Freedom program. Case study: Automation and robotics technology evaluation

NASA Technical Reports Server (NTRS)

Smith, Jeffrey H.; Levin, Richard R.; Carpenter, Elisabeth J.

1990-01-01

The results are described of an application of multiattribute analysis to the evaluation of high leverage prototyping technologies in the automation and robotics (A and R) areas that might contribute to the Space Station (SS) Freedom baseline design. An implication is that high leverage prototyping is beneficial to the SS Freedom Program as a means for transferring technology from the advanced development program to the baseline program. The process also highlights the tradeoffs to be made between subsidizing high value, low risk technology development versus high value, high risk technology developments. Twenty one A and R Technology tasks spanning a diverse array of technical concepts were evaluated using multiattribute decision analysis. Because of large uncertainties associated with characterizing the technologies, the methodology was modified to incorporate uncertainty. Eight attributes affected the rankings: initial cost, operation cost, crew productivity, safety, resource requirements, growth potential, and spinoff potential. The four attributes of initial cost, operations cost, crew productivity, and safety affected the rankings the most.

Effect of Smaller Left Ventricular Capture Threshold Safety Margins to Improve Device Longevity in Recipients of Cardiac Resynchronization-Defibrillation Therapy.

PubMed

Steinhaus, Daniel A; Waks, Jonathan W; Collins, Robert; Kleckner, Karen; Kramer, Daniel B; Zimetbaum, Peter J

2015-07-01

Device longevity in cardiac resynchronization therapy (CRT) is affected by the pacing capture threshold (PCT) and programmed pacing amplitude of the left ventricular (LV) pacing lead. The aims of this study were to evaluate the stability of LV pacing thresholds in a nationwide sample of CRT defibrillator recipients and to determine potential longevity improvements associated with a decrease in the LV safety margin while maintaining effective delivery of CRT. CRT defibrillator patients in the Medtronic CareLink database were eligible for inclusion. LV PCT stability was evaluated using ≥2 measurements over a 14-day period. Separately, a random sample of 7,250 patients with programmed right atrial and right ventricular amplitudes ≤2.5 V, LV thresholds ≤ 2.5 V, and LV pacing ≥90% were evaluated to estimate theoretical battery longevity improvement using LV safety margins of 0.5 and 1.5 V. Threshold stability analysis in 43,256 patients demonstrated LV PCT stability of <0.5 V in 77% of patients and <1 V in 95%. Device longevity analysis showed that the use of a 0.5-V safety margin increased average battery longevity by 0.62 years (95% confidence interval 0.61 to 0.63) compared with a safety margin of 1.5 V. Patients with LV PCTs >1 V had the greatest increases in battery life (mean increase 0.86 years, 95% confidence interval 0.85 to 0.87). In conclusion, nearly all CRT defibrillator patients had LV PCT stability <1.0 V. Decreasing the LV safety margin from 1.5 to 0.5 V provided consistent delivery of CRT for most patients and significantly improved battery longevity. Copyright © 2015 Elsevier Inc. All rights reserved.

Using modeling and rehearsal to teach fire safety to children with autism.

PubMed

Garcia, David; Dukes, Charles; Brady, Michael P; Scott, Jack; Wilson, Cynthia L

2016-09-01

We evaluated the efficacy of an instructional procedure to teach young children with autism to evacuate settings and notify an adult during a fire alarm. A multiple baseline design across children showed that an intervention that included modeling, rehearsal, and praise was effective in teaching fire safety skills. Safety skills generalized to novel settings and maintained during a 5-week follow-up in both training and generalization settings. © 2016 Society for the Experimental Analysis of Behavior.

Solving a product safety problem using a recycled high density polyethylene container

NASA Technical Reports Server (NTRS)

Liu, Ping; Waskom, T. L.

1993-01-01

The objectives are to introduce basic problem-solving techniques for product safety including problem identification, definition, solution criteria, test process and design, and data analysis. The students are given a recycled milk jug made of high density polyethylene (HDPE) by blow molding. The objectives are to design and perform proper material test(s) so they can evaluate the product safety if the milk jug is used in a certain way which is specified in the description of the procedure for this investigation.

Research on public participant urban infrastructure safety monitoring system using smartphone

NASA Astrophysics Data System (ADS)

Zhao, Xuefeng; Wang, Niannian; Ou, Jinping; Yu, Yan; Li, Mingchu

2017-04-01

Currently more and more people concerned about the safety of major public security. Public participant urban infrastructure safety monitoring and investigation has become a trend in the era of big data. In this paper, public participant urban infrastructure safety protection system based on smart phones is proposed. The system makes it possible to public participant disaster data collection, monitoring and emergency evaluation in the field of disaster prevention and mitigation. Function of the system is to monitor the structural acceleration, angle and other vibration information, and extract structural deformation and implement disaster emergency communications based on smartphone without network. The monitoring data is uploaded to the website to create urban safety information database. Then the system supports big data analysis processing, the structure safety assessment and city safety early warning.

Study of a safety margin system for powered-lift STOL aircraft

NASA Technical Reports Server (NTRS)

Heffley, R. K.; Jewell, W. F.

1978-01-01

A study was conducted to explore the feasibility of a safety margin system for powered-lift aircraft which require a backside piloting technique. The objective of the safety margin system was to present multiple safety margin criteria as a single variable which could be tracked manually or automatically and which could be monitored for the purpose of deriving safety margin status. The study involved a pilot-in-the-loop analysis of several safety margin system concepts and a simulation experiment to evaluate those concepts which showed promise of providing a good solution. A system was ultimately configured which offered reasonable compromises in controllability, status information content, and the ability to regulate the safety margin at some expense of the allowable low speed flight path envelope.

Vessel traffic safety in busy waterways: A case study of accidents in western shenzhen port.

PubMed

Mou, J M; Chen, P F; He, Y X; Yip, Tsz Leung; Li, W H; Tang, J; Zhang, H Z

2016-08-03

Throughout the world, busy waterways near large ports witness heavy vessel traffic in recent decades. The waterways are characterized by high risk in terms of loss of life, property, and pollution to environment. To facilitate maritime safety management with satisfactory efficiency and efficacy, the authors propose a framework of safety indexes to evaluate the risk level in busy waterways according to the accident severity, fatality rate and special indicators of maritime transportation. The safety indexes consist of Safety Evaluation Index (SEI) and Safety Warning Index (SWI), and are derived from the proposed risk criteria of Chinese vessel traffic. As a case study, data on vessel traffic accidents reported in the Western Shenzhen Port, South China from 1995 to 2015 are analyzed. The actual risk level of this area during the period is calculated under the framework. The implementation of the safety indexes indicate that the risk criteria and safety indexes are practicable and effective for the vessel traffic management. The methodology based on long-term accident data can significantly support the risk analysis in the macroscopic perspective for busy ports and waterways, such that SWI can act as threshold to trigger actions, while SEI can act as an indicator to measure safety status. Copyright © 2016 Elsevier Ltd. All rights reserved.

Design and analysis of sustainable paper bicycle

NASA Astrophysics Data System (ADS)

Roni Sahroni, Taufik; Nasution, Januar

2017-12-01

This paper presents the design of sustainable paper bicycle which describes the stage by stage in the production of paper bicycle. The objective of this project is to design a sustainable paper bicycles to be used for children under five years old. The design analysis emphasizes in screening method to ensure the design fulfil the safety purposes. The evaluation concept is presented in designing a sustainable paper bicycle to determine highest rating. Project methodology is proposed for developing a sustainable paper bicycle. Design analysis of pedal, front and rear wheel, seat, and handle were presented using AutoCAD software. The design optimization was performed to fulfil the safety factors by modifying the material size and dimension. Based on the design analysis results, it is found that the optimization results met the factor safety. As a result, a sustainable paper bicycle was proposed for children under five years old.

Experimental Design for Evaluating the Safety Benefits of Railroad Advance Warning Signs

DOT National Transportation Integrated Search

1979-04-01

The report presents the findings and conclusions of a study to develop an experimental design and analysis plan for field testing and evaluation of the accident reduction potential of a proposed new railroad grade crossing advance warning sign. Sever...

EXPERIENCES FROM THE SOURCE-TERM ANALYSIS OF A LOW AND INTERMEDIATE LEVEL RADWASTE DISPOSAL FACILITY

DOE Office of Scientific and Technical Information (OSTI.GOV)

Park,Jin Beak; Park, Joo-Wan; Lee, Eun-Young

2003-02-27

Enhancement of a computer code SAGE for evaluation of the Korean concept for a LILW waste disposal facility is discussed. Several features of source term analysis are embedded into SAGE to analyze: (1) effects of degradation mode of an engineered barrier, (2) effects of dispersion phenomena in the unsaturated zone and (3) effects of time dependent sorption coefficient in the unsaturated zone. IAEA's Vault Safety Case (VSC) approach is used to demonstrate the ability of this assessment code. Results of MASCOT are used for comparison purposes. These enhancements of the safety assessment code, SAGE, can contribute to realistic evaluation ofmore » the Korean concept of the LILW disposal project in the near future.« less

Automating the Generation of Heterogeneous Aviation Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.; Pohl, Josef M.

2012-01-01

A safety case is a structured argument, supported by a body of evidence, which provides a convincing and valid justification that a system is acceptably safe for a given application in a given operating environment. This report describes the development of a fragment of a preliminary safety case for the Swift Unmanned Aircraft System. The construction of the safety case fragment consists of two parts: a manually constructed system-level case, and an automatically constructed lower-level case, generated from formal proof of safety-relevant correctness properties. We provide a detailed discussion of the safety considerations for the target system, emphasizing the heterogeneity of sources of safety-relevant information, and use a hazard analysis to derive safety requirements, including formal requirements. We evaluate the safety case using three classes of metrics for measuring degrees of coverage, automation, and understandability. We then present our preliminary conclusions and make suggestions for future work.

The Interagency Nuclear Safety Review Panel's Galileo safety evaluation report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nelson, R.C.; Gray, L.B.; Huff, D.A.

The safety evaluation report (SER) for Galileo was prepared by the Interagency Nuclear Safety Review Panel (INSRP) coordinators in accordance with Presidential directive/National Security Council memorandum 25. The INSRP consists of three coordinators appointed by their respective agencies, the Department of Defense, the Department of Energy (DOE), and the National Aeronautics and Space Administration (NASA). These individuals are independent of the program being evaluated and depend on independent experts drawn from the national technical community to serve on the five INSRP subpanels. The Galileo SER is based on input provided by the NASA Galileo Program Office, review and assessment ofmore » the final safety analysis report prepared by the Office of Special Applications of the DOE under a memorandum of understanding between NASA and the DOE, as well as other related data and analyses. The SER was prepared for use by the agencies and the Office of Science and Technology Policy, Executive Office of the Present for use in their launch decision-making process. Although more than 20 nuclear-powered space missions have been previously reviewed via the INSRP process, the Galileo review constituted the first review of a nuclear power source associated with launch aboard the Space Transportation System.« less

[Results of a post-marketing surveillance of meropenem for febrile neutropenia].

PubMed

Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

2015-08-01

The post-marketing surveillance of meropenem (Meropen) for febrile neutropenia (FN) was conducted between July 2010 and June 2012 to evaluate safety and efficacy under actual clinical use. There were 1191 and 1124 evaluable cases for safety and efficacy respectively, of 1207 case cards collected from 180 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 15.7% (187/1191 cases), and the main ADRs were alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hepatic function abnormal, and liver disorder, which were similar to these observed in the clinical study for FN or post marketing surveillances of meropenem conducted before. In efficacy analysis, the overall efficacy was 81.8% (919/1124 cases). Also, it was 79.2% (708/894 cases) for hematological malignancy and 91.8% (213/232 cases) for solid cancer. These results confirmed meropenem (Meropen) is one of the well-tolerated and potent antimicrobial agents for febrile neutropenia.

Safety Assessment of Food and Feed from GM Crops in Europe: Evaluating EFSA's Alternative Framework for the Rat 90-day Feeding Study.

PubMed

Hong, Bonnie; Du, Yingzhou; Mukerji, Pushkor; Roper, Jason M; Appenzeller, Laura M

2017-07-12

Regulatory-compliant rodent subchronic feeding studies are compulsory regardless of a hypothesis to test, according to recent EU legislation for the safety assessment of whole food/feed produced from genetically modified (GM) crops containing a single genetic transformation event (European Union Commission Implementing Regulation No. 503/2013). The Implementing Regulation refers to guidelines set forth by the European Food Safety Authority (EFSA) for the design, conduct, and analysis of rodent subchronic feeding studies. The set of EFSA recommendations was rigorously applied to a 90-day feeding study in Sprague-Dawley rats. After study completion, the appropriateness and applicability of these recommendations were assessed using a battery of statistical analysis approaches including both retrospective and prospective statistical power analyses as well as variance-covariance decomposition. In the interest of animal welfare considerations, alternative experimental designs were investigated and evaluated in the context of informing the health risk assessment of food/feed from GM crops.

Safety evaluation of right-turn smart channels using automated traffic conflict analysis.

PubMed

Autey, Jarvis; Sayed, Tarek; Zaki, Mohamed H

2012-03-01

This paper presents the results of a before-after (BA) safety evaluation of a newly proposed design for channelized right-turn lanes. The new design, termed "Smart Channels", decreases the angle of the channelized right turn to approximately 70°. The implementation of these modified right-turn channels is usually advocated to allow for safer pedestrian crossing. However, the benefits also extend to vehicle-vehicle interactions since the new approach angle affords drivers a better view of the traffic stream they are to merge with. The evaluation is conducted using a video-based automated traffic conflict analysis. There are several advantages that support the adoption of traffic conflict techniques in BA safety studies. Traffic conflicts are more frequent than road collisions and are of marginal social cost, they provide insight into the failure mechanism that leads to road collisions, and BA studies based on traffic conflicts can be conducted over shorter periods. As well, the use of automated conflict analysis overcomes the reliability and repeatability problems usually associated with manual conflict observations. Data for three treatment intersections and one control intersection in Penticton, British Columbia, are used in this study. The results of the evaluation show that the implementation of the right-turn treatment has resulted in a considerable reduction in the severity and frequency of merging, rear-end, and total conflicts. The total average hourly conflict was reduced by about 51% while the average conflict severity was reduced by 41%. Copyright © 2011 Elsevier Ltd. All rights reserved.

Reporting of methodological features in observational studies of pre-harvest food safety.

PubMed

Sargeant, Jan M; O'Connor, Annette M; Renter, David G; Kelton, David F; Snedeker, Kate; Wisener, Lee V; Leonard, Erin K; Guthrie, Alessia D; Faires, Meredith

2011-02-01

Observational studies in pre-harvest food safety may be useful for identifying risk factors and for evaluating potential mitigation strategies to reduce foodborne pathogens. However, there are no structured reporting guidelines for these types of study designs in livestock species. Our objective was to evaluate the reporting of observational studies in the pre-harvest food safety literature using guidelines modified from the human healthcare literature. We identified 100 pre-harvest food safety studies published between 1999 and 2009. Each study was evaluated independently by two reviewers using a structured checklist. Of the 38 studies that explicitly stated the observational study design, 27 were described as cross-sectional studies, eight as case-control studies, and three as cohort studies. Study features reported in over 75% of the selected studies included: description of the geographic location of the studies, definitions and sources of data for outcomes, organizational level and source of data for independent variables, description of statistical methods and results, number of herds enrolled in the study and included in the analysis, and sources of study funding. However, other features were not consistently reported, including details related to eligibility criteria for groups (such as barn, room, or pen) and individuals, numbers of groups and individuals included in various stages of the study, identification of primary outcomes, the distinction between putative risk factors and confounding variables, the identification of a primary exposure variable, the referent level for evaluation of categorical variable associations, methods of controlling confounding variables and missing variables, model fit, details of subset analysis, demographic information at the sampling unit level, and generalizability of the study results. Improvement in reporting of observational studies of pre-harvest food safety will aid research readers and reviewers in interpreting and evaluating the results of such studies. Copyright © 2010 Elsevier B.V. All rights reserved.

A new method to evaluate future impact of vehicle safety technology in Sweden.

PubMed

Strandroth, Johan; Sternlund, Simon; Tingvall, Claes; Johansson, Roger; Rizzi, Matteo; Kullgren, Anders

2012-10-01

In the design of a safe road transport system there is a need to better understand the safety challenges lying ahead. One way of doing that is to evaluate safety technology with retrospective analysis of crashes. However, by using retros- pective data there is the risk of adapting safety innovations to scenarios irrelevant in the future. Also, challenges arise as safety interventions do not act alone but are rather interacting components in a complex road transport system. The objective of this study was therefore to facilitate the prioritizing of road safety measures by developing and applying a new method to consider possible impact of future vehicle safety technology. The key point was to project the chain of events leading to a crash today into the crashes for a given time in the future. Assumptions on implementation on safety technologies were made and these assump- tions were applied on the crashes of today. It was estimated which crashes would be prevented and the residual was analyzed to identify the characteristics of future crashes. The Swedish Transport Administration's in-depth studies of fatal crashes from 2010 involving car passengers (n=156) were used. This study estimated that the number of killed car occupant would be reduced with 53 percent from the year 2010 to 2020. Through this new method, valuable information regarding the characteristic of the future crashes was found. The results of this study showed that it was possible to evaluate future impact of vehicle safety technology if detailed and representative crash data is available.

Sequence analysis of CVI988-based vaccine, pCVI988-699-2-RV that has undergone a reversion to virulence

USDA-ARS?s Scientific Manuscript database

In our safety evaluation of CVI988-699-2delta, a vaccine derived from a bacterial artificial chromosome (BAC)-based infectious clone of low passage CVI988, we found that the virus reverted to virulence during a safety trial using specific pathogen free (SPF) leghorn chickens. To determine changes i...

A System for Integrated Reliability and Safety Analyses

NASA Technical Reports Server (NTRS)

Kostiuk, Peter; Shapiro, Gerald; Hanson, Dave; Kolitz, Stephan; Leong, Frank; Rosch, Gene; Coumeri, Marc; Scheidler, Peter, Jr.; Bonesteel, Charles

1999-01-01

We present an integrated reliability and aviation safety analysis tool. The reliability models for selected infrastructure components of the air traffic control system are described. The results of this model are used to evaluate the likelihood of seeing outcomes predicted by simulations with failures injected. We discuss the design of the simulation model, and the user interface to the integrated toolset.

Systematic review and meta-analysis of the efficacy and safety of alendronate and zoledronate for the treatment of postmenopausal osteoporosis.

PubMed

Serrano, Ana Julissa; Begoña, Leire; Anitua, Eduardo; Cobos, Raquel; Orive, Gorka

2013-12-01

The aim of this meta-analysis was to evaluate the efficacy and safety of two bisphosphonates (alendronate and zoledronate) in the treatment of postmenopausal osteoporosis. The incidence of fractures was considered as primary endpoint. Only randomized trials with a follow-up period of 1 year or more were included in this systematic review and meta-analysis. We excluded studies that included patients with secondary osteoporosis especially in relation to therapy with corticosteroids or other drugs or diseases known to affect bone mineral density. Studies published as subgroup analysis, extension studies, economic evaluations, and comparisons with active control were excluded. The methodological quality of controlled clinical trials that met these inclusion criteria was evaluated. No studies were excluded from analysis due to lack of quality. The risk ratio of hip, vertebral and wrist fractures for alendronate were 0.61 [95% confidence interval (CI) 0.40-0.93], 0.54 (95% CI 0.44-0.66) and 0.65 (95% CI 0.33-1.25), respectively. Zoledronate risk ratio was 0.62 (95% CI 0.46-0.82) and 0.38 (95% CI 0.22-0.67) for hip and vertebral fractures, respectively.

Effectiveness of Direct Safety Regulations on Manufacturers and Users of Industrial Machines: Its Implications on Industrial Safety Policies in Republic of Korea.

PubMed

Choi, Gi Heung

2017-03-01

Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.

Linking Environmental Sustainability, Health, and Safety Data in Health Care: A Research Roadmap.

PubMed

Kaplan, Susan B; Forst, Linda

2017-08-01

Limited but growing evidence demonstrates that environmental sustainability in the health-care sector can improve worker and patient health and safety. Yet these connections are not appreciated or understood by decision makers in health-care organizations or oversight agencies. Several studies demonstrate improvements in quality of care, staff satisfaction, and work productivity related to environmental improvements in the health-care sector. A pilot study conducted by the authors found that already-collected data could be used to evaluate impacts of environmental sustainability initiatives on worker and patient health and safety, yet few hospitals do so. Future research should include a policy analysis of laws that could drive efforts to integrate these areas, elucidation of organizational models that promote sharing of environmental and health and safety data, and development of tools and methods to enable systematic linkage and evaluation of these data to expand the evidence base and improve the hospital environment.

Science, safety, and trust: the case of transgenic food.

PubMed

Martinelli, Lucia; Karbarz, Małgorzata; Siipi, Helena

2013-02-01

Genetically modified (GM) food is discussed as an example of the controversial relation between the intrinsic uncertainty of the scientific approach and the demand of citizen-consumers to use products of science innovation that are known to be safe. On the whole, peer-reviewed studies on GM food safety do not note significant health risks, with a few exceptions, like the most renowned "Pusztai affair" and the recent "Seralini case." These latter studies have been disregarded by the scientific community, based on incorrect experimental designs and statistic analysis. Such contradictory results show the complexity of risk evaluation, and raise concerns in the citizen-consumers against the GM food. A thoughtful consideration by scientific community and decision makers of the moral values that are present in risk evaluation and risk management should be the most trustable answer to citizen-consumers to their claim for clear and definitive answers concerning safety/un-safety of GM food.

[Validation of a questionnaire to evaluate patient safety in clinical laboratories].

PubMed

Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

2012-01-01

The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

An Economic Evaluation of Food Safety Education Interventions: Estimates and Critical Data Gaps.

PubMed

Zan, Hua; Lambea, Maria; McDowell, Joyce; Scharff, Robert L

2017-08-01

The economic evaluation of food safety interventions is an important tool that practitioners and policy makers use to assess the efficacy of their efforts. These evaluations are built on models that are dependent on accurate estimation of numerous input variables. In many cases, however, there is no data available to determine input values and expert opinion is used to generate estimates. This study uses a benefit-cost analysis of the food safety component of the adult Expanded Food and Nutrition Education Program (EFNEP) in Ohio as a vehicle for demonstrating how results based on variable values that are not objectively determined may be sensitive to alternative assumptions. In particular, the focus here is on how reported behavioral change is translated into economic benefits. Current gaps in the literature make it impossible to know with certainty how many people are protected by the education (what are the spillover effects?), the length of time education remains effective, and the level of risk reduction from change in behavior. Based on EFNEP survey data, food safety education led 37.4% of participants to improve their food safety behaviors. Under reasonable default assumptions, benefits from this improvement significantly outweigh costs, yielding a benefit-cost ratio of between 6.2 and 10.0. Incorporation of a sensitivity analysis using alternative estimates yields a greater range of estimates (0.2 to 56.3), which highlights the importance of future research aimed at filling these research gaps. Nevertheless, most reasonable assumptions lead to estimates of benefits that justify their costs.

Validity and consistency assessment of accident analysis methods in the petroleum industry.

PubMed

Ahmadi, Omran; Mortazavi, Seyed Bagher; Khavanin, Ali; Mokarami, Hamidreza

2017-11-17

Accident analysis is the main aspect of accident investigation. It includes the method of connecting different causes in a procedural way. Therefore, it is important to use valid and reliable methods for the investigation of different causal factors of accidents, especially the noteworthy ones. This study aimed to prominently assess the accuracy (sensitivity index [SI]) and consistency of the six most commonly used accident analysis methods in the petroleum industry. In order to evaluate the methods of accident analysis, two real case studies (process safety and personal accident) from the petroleum industry were analyzed by 10 assessors. The accuracy and consistency of these methods were then evaluated. The assessors were trained in the workshop of accident analysis methods. The systematic cause analysis technique and bowtie methods gained the greatest SI scores for both personal and process safety accidents, respectively. The best average results of the consistency in a single method (based on 10 independent assessors) were in the region of 70%. This study confirmed that the application of methods with pre-defined causes and a logic tree could enhance the sensitivity and consistency of accident analysis.

Software Dependability and Safety Evaluations ESA's Initiative

NASA Astrophysics Data System (ADS)

Hernek, M.

ESA has allocated funds for an initiative to evaluate Dependability and Safety methods of Software. The objectives of this initiative are; · More extensive validation of Safety and Dependability techniques for Software · Provide valuable results to improve the quality of the Software thus promoting the application of Dependability and Safety methods and techniques. ESA space systems are being developed according to defined PA requirement specifications. These requirements may be implemented through various design concepts, e.g. redundancy, diversity etc. varying from project to project. Analysis methods (FMECA. FTA, HA, etc) are frequently used during requirements analysis and design activities to assure the correct implementation of system PA requirements. The criticality level of failures, functions and systems is determined and by doing that the critical sub-systems are identified, on which dependability and safety techniques are to be applied during development. Proper performance of the software development requires the development of a technical specification for the products at the beginning of the life cycle. Such technical specification comprises both functional and non-functional requirements. These non-functional requirements address characteristics of the product such as quality, dependability, safety and maintainability. Software in space systems is more and more used in critical functions. Also the trend towards more frequent use of COTS and reusable components pose new difficulties in terms of assuring reliable and safe systems. Because of this, its dependability and safety must be carefully analysed. ESA identified and documented techniques, methods and procedures to ensure that software dependability and safety requirements are specified and taken into account during the design and development of a software system and to verify/validate that the implemented software systems comply with these requirements [R1].

Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial.

PubMed

Friedman, A J; Wheeler, J

1991-04-01

A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA 1 mg with EE 35 micrograms for one to eight months. Clinical evaluation forms on 6,382 patients were amenable to analysis for safety (including breakthrough bleeding, ovarian cyst formation and complexion changes); 5,412 patients were evaluable for efficacy (prevention of pregnancy), with a total of 21,440 cycles recorded. The study results were interpreted in terms of the impact on clinical management of oral contraceptive users and the methods, strengths and weaknesses of phase IV trials, particularly as they relate to confirmation of the results reported here.

NASA Range Safety Annual Report 2007

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2007-01-01

As always, Range Safety has been involved in a number of exciting and challenging activities and events. Throughout the year, we have strived to meet our goal of protecting the public, the workforce, and property during range operations. During the past year, Range Safety was involved in the development, implementation, and support of range safety policy. Range Safety training curriculum development was completed this year and several courses were presented. Tailoring exercises concerning the Constellation Program were undertaken with representatives from the Constellation Program, the 45th Space Wing, and the Launch Constellation Range Safety Panel. Range Safety actively supported the Range Commanders Council and it subgroups and remained involved in updating policy related to flight safety systems and flight safety analysis. In addition, Range Safety supported the Space Shuttle Range Safety Panel and addressed policy concerning unmanned aircraft systems. Launch operations at Kennedy Space Center, the Eastern and Western ranges, Dryden Flight Research Center, and Wallops Flight Facility were addressed. Range Safety was also involved in the evaluation of a number of research and development efforts, including the space-based range (formerly STARS), the autonomous flight safety system, the enhanced flight termination system, and the joint advanced range safety system. Flight safety system challenges were evaluated. Range Safety's role in the Space Florida Customer Assistance Service Program for the Eastern Range was covered along with our support for the Space Florida Educational Balloon Release Program. We hope you have found the web-based format both accessible and easy to use. Anyone having questions or wishing to have an article included in the 2008 Range Safety Annual Report should contact Alan Dumont, the NASA Range Safety Program Manager located at the Kennedy Space Center, or Michael Dook at NASA Headquarters.

Safety Guided Design of Crew Return Vehicle in Concept Design Phase Using STAMP/STPA

NASA Astrophysics Data System (ADS)

Nakao, H.; Katahira, M.; Miyamoto, Y.; Leveson, N.

2012-01-01

In the concept development and design phase of a new space system, such as a Crew Vehicle, designers tend to focus on how to implement new technology. Designers also consider the difficulty of using the new technology and trade off several system design candidates. Then they choose an optimal design from the candidates. Safety should be a key aspect driving optimal concept design. However, in past concept design activities, safety analysis such as FTA has not used to drive the design because such analysis techniques focus on component failure and component failure cannot be considered in the concept design phase. The solution to these problems is to apply a new hazard analysis technique, called STAMP/STPA. STAMP/STPA defines safety as a control problem rather than a failure problem and identifies hazardous scenarios and their causes. Defining control flow is the essential in concept design phase. Therefore STAMP/STPA could be a useful tool to assess the safety of system candidates and to be part of the rationale for choosing a design as the baseline of the system. In this paper, we explain our case study of safety guided concept design using STPA, the new hazard analysis technique, and model-based specification technique on Crew Return Vehicle design and evaluate benefits of using STAMP/STPA in concept development phase.

Structural Evaluation of the RSRM Nozzle Replacement Adhesive

NASA Technical Reports Server (NTRS)

Batista-Rodriguez, A.; McLennan, M. L.; Palumbos, A. V.; Richardson, D. E.

1999-01-01

This paper describes the structural performance evaluation of a replacement adhesive for the Reusable Solid Rocket Motor (RSRM) nozzle utilizing finite element analysis. Due to material obsolescence and industrial safety issues, the two current structural adhesives, EA 913 and EA 946 are to be replaced with a new adhesive. TIGA 321. The structural evaluation in support of the adhesive replacement effort includes residual stress, transportation, and flight analyses. Factors of safety are calculated using the stress response from each analysis. The factors of safety are used as the limiting criteria to compare the replacement adhesive against the current adhesives. Included in this paper are the analytical approach, assumptions and modeling techniques as well as the results of the evaluation. An important factor to the evaluation is the similarity in constitutive material properties (elastic modulus and Poisson's ratio) between TIGA 321 and EA 913. This similarity leads to equivalent material response from the two adhesives. However, TIGA 321 surpasses EA 913's performance due to higher material capabilities. Conversely, the change in stress response from EA 946 to TIGA 321 is more apparent: this is primarily attributed to the difference in the modulii of the two adhesives, which differ by two orders of magnitude. The results of the bondline evaluation indicate that the replacement adhesive provides superior performance than the current adhesives with only minor exceptions. Furthermore, TIGA 321 causes only a minor chance in the response of the phenolic and metal components.

Toxicity and Bio-Safety Evaluation of Magnetic Nanocrystals Designed for Nano-Medical Sensors

DTIC Science & Technology

2006-09-15

0 E. TRAVEL $ 5,500 Jinwoo Cheon Taejeon (ETRI), research meeting $ 300X5 =$1500 Seung - won Park...KRICT), GC analysis $80 Prepaid expenditures Jin-sil Choi Taejeon (KBSI), TEM analysis $40X28 = $1120 Jinwoo Cheon

Occupational safety beliefs among Latino residential roofing workers.

PubMed

Arcury, Thomas A; Summers, Phillip; Carrillo, Lourdes; Grzywacz, Joseph G; Quandt, Sara A; Mills, Thomas H

2014-06-01

This analysis describes beliefs about work safety and personal protective equipment (PPE) among Latino roofing workers, it delineates their perceptions of work environment characteristics that affect work safety and PPE use, and it describes how they experience work injuries and the consequences of these injuries. In-depth interviews were completed with 10 current and former Latino residential roofers. Interview transcripts were subjected to systematic qualitative analysis. Participants' valued productivity over safety, and this had a negative influence on their safety behavior and reduced their PPE use. They understood that roofing was hazardous. They limited use of PPE when they felt it reduced productivity and when it was uncomfortable. Work environment characteristics that affected safety included company size, the physical demands of the job, lack of training, the need for work, general life stress, and distractions at work. An injury had to result in lost work time to be considered significant. Access to health care is limited by employers not providing Workers' compensation. Future research is needed to substantiate these descriptive results and to delineate factors that are associated with safety behavior and use of PPE. Interventions, based on a lay health educator model, are needed to improve safety in this population. Safety regulations need to be evaluated and their enforcement needs to be improved. © 2013 Wiley Periodicals, Inc.

Strategies to reduce safety violations for working from heights in construction companies: study protocol for a randomized controlled trial.

PubMed

van der Molen, Henk F; Frings-Dresen, Monique H W

2014-05-31

Safety measures should be applied to reduce work-related fatal and non-fatal fall injuries. However, according to the labor inspectorate, more than 80% of Dutch construction sites violate safety regulations for working from heights. To increase compliance with safety regulations, employers and workers have to select, implement and monitor safety measures. To facilitate this behavioral change, stimulating knowledge awareness and personalized feedback are frequently advocated behavior change techniques. For this study, two behavior change strategies have been developed in addition to the announcement of safety inspections by the labor inspectorate. These strategies consist of 1) face-to-face contacts with safety consultants and 2) direct mail with access to internet facilities. The objective of this study is to evaluate the effectiveness of these two strategies on the safety violations for working from heights, the process and the cost measures. This study is a block randomized intervention trial in 27 cities to establish the effects of the face-to-face guidance strategy (N = 9), a direct mailing strategy (N = 9) and a control condition of no guidance (N = 9) on safety violations to record by labor inspectors after three months. A process evaluation for both strategies will be performed to determine program implementation (reach, dose delivered and dose received), satisfaction, knowledge and perceived safety behavior. A cost analysis will be performed to establish the financial costs for both strategies. The present study is in accordance with the CONSORT statement. This study increases insight into performing practice-based randomized controlled trials. The outcome will help to evaluate the effect of two guidance strategies on safety violations. If these strategies are effective, implementation of these strategies through the national institute of safety and health or labor inspectorate can take place to guide construction companies in complying with safety regulations. NTR 4298 on 29-nov-2013.

An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials

PubMed Central

2011-01-01

Background Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Methods Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. Results Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting. For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). Conclusions An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement. PMID:21859470

Economic evaluation of occupational safety preventive measures in a hospital.

PubMed

Ramos, Delfina G; Arezes, Pedro M; Afonso, Paulo

2015-01-01

When an organization performs an integrated analysis of risks through its Occupational Health and Safety Management System, several steps are suggested to address the implications of the identified risks. Namely, the organization should make a detailed analysis of the monetary impact for the organization of each of the preventive measures considered. However, it is also important to perform an analysis of the impact of each measure on society (externalities). The aim of this paper is to present a case study related to the application of the proposed economic evaluation methodology. An analysis of the work accidents in a hospital has been made. Three of the major types of accidents have been selected: needle stings, falls and excessive strain. Following the risk assessment, some preventive measures have been designed. Subsequently, the Benefit/Cost ratio (B/C) of these measures has been calculated, both in financial terms (from the organization's perspective) and in economic terms (including the benefits for the worker and for the Society). While the financial ratio is only advantageous in some cases, when the externalities are taken into account, the B/C ratio increases significantly. It is important to consider external benefits to make decisions concerning the implementation of preventive measures in Occupational Health and Safety projects.

Interpreting the biological relevance of bioinformatic analyses with T-DNA sequence for protein allergenicity.

PubMed

Harper, B; McClain, S; Ganko, E W

2012-08-01

Global regulatory agencies require bioinformatic sequence analysis as part of their safety evaluation for transgenic crops. Analysis typically focuses on encoded proteins and adjacent endogenous flanking sequences. Recently, regulatory expectations have expanded to include all reading frames of the inserted DNA. The intent is to provide biologically relevant results that can be used in the overall assessment of safety. This paper evaluates the relevance of assessing the allergenic potential of all DNA reading frames found in common food genes using methods considered for the analysis of T-DNA sequences used in transgenic crops. FASTA and BLASTX algorithms were used to compare genes from maize, rice, soybean, cucumber, melon, watermelon, and tomato using international regulatory guidance. Results show that BLASTX for maize yielded 7254 alignments that exceeded allergen similarity thresholds and 210,772 alignments that matched eight or more consecutive amino acids with an allergen; other crops produced similar results. This analysis suggests that each nontransgenic crop has a much greater potential for allergenic risk than what has been observed clinically. We demonstrate that a meaningful safety assessment is unlikely to be provided by using methods with inherently high frequencies of false positive alignments when broadly applied to all reading frames of DNA sequence. Copyright © 2012 Elsevier Inc. All rights reserved.

Analysis of indoor air pollutants checklist using environmetric technique for health risk assessment of sick building complaint in nonindustrial workplace

PubMed Central

Syazwan, AI; Rafee, B Mohd; Juahir, Hafizan; Azman, AZF; Nizar, AM; Izwyn, Z; Syahidatussyakirah, K; Muhaimin, AA; Yunos, MA Syafiq; Anita, AR; Hanafiah, J Muhamad; Shaharuddin, MS; Ibthisham, A Mohd; Hasmadi, I Mohd; Azhar, MN Mohamad; Azizan, HS; Zulfadhli, I; Othman, J; Rozalini, M; Kamarul, FT

2012-01-01

Purpose To analyze and characterize a multidisciplinary, integrated indoor air quality checklist for evaluating the health risk of building occupants in a nonindustrial workplace setting. Design A cross-sectional study based on a participatory occupational health program conducted by the National Institute of Occupational Safety and Health (Malaysia) and Universiti Putra Malaysia. Method A modified version of the indoor environmental checklist published by the Department of Occupational Health and Safety, based on the literature and discussion with occupational health and safety professionals, was used in the evaluation process. Summated scores were given according to the cluster analysis and principal component analysis in the characterization of risk. Environmetric techniques was used to classify the risk of variables in the checklist. Identification of the possible source of item pollutants was also evaluated from a semiquantitative approach. Result Hierarchical agglomerative cluster analysis resulted in the grouping of factorial components into three clusters (high complaint, moderate-high complaint, moderate complaint), which were further analyzed by discriminant analysis. From this, 15 major variables that influence indoor air quality were determined. Principal component analysis of each cluster revealed that the main factors influencing the high complaint group were fungal-related problems, chemical indoor dispersion, detergent, renovation, thermal comfort, and location of fresh air intake. The moderate-high complaint group showed significant high loading on ventilation, air filters, and smoking-related activities. The moderate complaint group showed high loading on dampness, odor, and thermal comfort. Conclusion This semiquantitative assessment, which graded risk from low to high based on the intensity of the problem, shows promising and reliable results. It should be used as an important tool in the preliminary assessment of indoor air quality and as a categorizing method for further IAQ investigations and complaints procedures. PMID:23055779

Analysis of indoor air pollutants checklist using environmetric technique for health risk assessment of sick building complaint in nonindustrial workplace.

PubMed

Syazwan, Ai; Rafee, B Mohd; Juahir, Hafizan; Azman, Azf; Nizar, Am; Izwyn, Z; Syahidatussyakirah, K; Muhaimin, Aa; Yunos, Ma Syafiq; Anita, Ar; Hanafiah, J Muhamad; Shaharuddin, Ms; Ibthisham, A Mohd; Hasmadi, I Mohd; Azhar, Mn Mohamad; Azizan, Hs; Zulfadhli, I; Othman, J; Rozalini, M; Kamarul, Ft

2012-01-01

To analyze and characterize a multidisciplinary, integrated indoor air quality checklist for evaluating the health risk of building occupants in a nonindustrial workplace setting. A cross-sectional study based on a participatory occupational health program conducted by the National Institute of Occupational Safety and Health (Malaysia) and Universiti Putra Malaysia. A modified version of the indoor environmental checklist published by the Department of Occupational Health and Safety, based on the literature and discussion with occupational health and safety professionals, was used in the evaluation process. Summated scores were given according to the cluster analysis and principal component analysis in the characterization of risk. Environmetric techniques was used to classify the risk of variables in the checklist. Identification of the possible source of item pollutants was also evaluated from a semiquantitative approach. Hierarchical agglomerative cluster analysis resulted in the grouping of factorial components into three clusters (high complaint, moderate-high complaint, moderate complaint), which were further analyzed by discriminant analysis. From this, 15 major variables that influence indoor air quality were determined. Principal component analysis of each cluster revealed that the main factors influencing the high complaint group were fungal-related problems, chemical indoor dispersion, detergent, renovation, thermal comfort, and location of fresh air intake. The moderate-high complaint group showed significant high loading on ventilation, air filters, and smoking-related activities. The moderate complaint group showed high loading on dampness, odor, and thermal comfort. This semiquantitative assessment, which graded risk from low to high based on the intensity of the problem, shows promising and reliable results. It should be used as an important tool in the preliminary assessment of indoor air quality and as a categorizing method for further IAQ investigations and complaints procedures.

Plutonium Oxide Containment and the Potential for Water-Borne Transport as a Consequence of ARIES Oxide Processing Operations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wayne, David Matthew; Rowland, Joel C.

2015-02-01

The question of oxide containment during processing and storage has become a primary concern when considering the continued operability of the Plutonium Facility (PF-4) at Los Alamos National Laboratory (LANL). An Evaluation of the Safety of the Situation (ESS), “Potential for Criticality in a Glovebox Due to a Fire” (TA55-ESS-14-002-R2, since revised to R3) first issued in May, 2014 summarizes these concerns: “The safety issue of fire water potentially entering a glovebox is: the potential for the water to accumulate in the bottom of a glovebox and result in an inadvertent criticality due to the presence of fissionable materials inmore » the glovebox locations and the increased reflection and moderation of neutrons from the fire water accumulation.” As a result, the existing documented safety analysis (DSA) was judged inadequate and, while it explicitly considered the potential for criticality resulting from water intrusion into gloveboxes, criticality safety evaluation documents (CSEDs) for the affected locations did not evaluate the potential for fire water intrusion into a glovebox.« less

Parental safety concerns and active school commute: correlates across multiple domains in the home-to-school journey

PubMed Central

2014-01-01

Background Empirical evidence of the relationship between safety concerns and walking to school (WTS) is growing. However, current research offers limited understanding of the multiple domains of parental safety concerns and the specific mechanisms through which parents articulate safety concerns about WTS. A more detailed understanding is needed to inform environmental and policy interventions. This study examined the relationships between both traffic safety and personal safety concerns and WTS in the U.S. Methods This cross-sectional analysis examined data from the Texas Childhood Obesity Prevention Policy Evaluation (T-COPPE) project, an evaluation of state-wide obesity prevention policy interventions. All study data were from the survey (n = 830) of parents with 4th grade students attending 81 elementary schools across Texas, and living within two miles from their children's schools. Traffic safety and personal safety concerns were captured for the home neighborhood, en-route to school, and school environments. Binary logistic regression analysis was used to assess the odds of WTS controlling for significant covariates. Results Overall, 18% of parents reported that their child walked to school on most days of the week. For traffic safety, students were more likely to walk to school if their parent reported favorable perceptions about the following items in the home neighborhood environment: higher sidewalk availability, well maintained sidewalks and safe road crossings. For the route to school, the odds of WTS were higher for those who reported "no problem" with each one of the following: traffic speed, amount of traffic, sidewalks/pathways, intersection/crossing safety, and crossing guards, when compared to those that reported "always a problem". For personal safety in the en-route to school environment, the odds of WTS were lower when parents reported concerns about: stray or dangerous animals and availability of others with whom to walk. Conclusions Findings offered insights into the specific issues that drive safety concerns for elementary school children’s WTS behaviors. The observed associations between more favorable perceptions of safety and WTS provide further justification for practical intervention strategies to reduce WTS barriers that can potentially bring long-term physical activity and health benefits to school-aged children. PMID:24602213

10 CFR 2.1003 - Availability of material.

Code of Federal Regulations, 2010 CFR

2010-01-01

...; (xiv) Graphs, plots, strip charts, sketches; (xv) Descriptive material related to the information..., such as the Site Characterization Analysis, and the Safety Evaluation Report, shall be made available...

76 FR 26301 - Decision To Evaluate a Petition To Designate a Class of Employees From the Y-12 Plant in Oak...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-06

... evaluation, is as follows: Facility: Y-12 Plant. Location: Oak Ridge, TN. Job Titles and/or Job Duties: All... Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway...

78 FR 65426 - Technical Report: Evaluation of the Certified-Advanced Air Bags

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... INFORMATION CONTACT: Nathan K. Greenwell, Mathematical Statistician, Evaluation Division, NVS-431, National Center for Statistics and Analysis, National Highway Traffic Safety Administration, Room W53-438, 1200... bags at all for children, using occupant detection sensors to suppress the air bags. Statistical...

Applying Qualitative Hazard Analysis to Support Quantitative Safety Analysis for Proposed Reduced Wake Separation Conops

NASA Technical Reports Server (NTRS)

Shortle, John F.; Allocco, Michael

2005-01-01

This paper describes a scenario-driven hazard analysis process to identify, eliminate, and control safety-related risks. Within this process, we develop selective criteria to determine the applicability of applying engineering modeling to hypothesized hazard scenarios. This provides a basis for evaluating and prioritizing the scenarios as candidates for further quantitative analysis. We have applied this methodology to proposed concepts of operations for reduced wake separation for closely spaced parallel runways. For arrivals, the process identified 43 core hazard scenarios. Of these, we classified 12 as appropriate for further quantitative modeling, 24 that should be mitigated through controls, recommendations, and / or procedures (that is, scenarios not appropriate for quantitative modeling), and 7 that have the lowest priority for further analysis.

Progress of IRSN R&D on ITER Safety Assessment

NASA Astrophysics Data System (ADS)

Van Dorsselaere, J. P.; Perrault, D.; Barrachin, M.; Bentaib, A.; Gensdarmes, F.; Haeck, W.; Pouvreau, S.; Salat, E.; Seropian, C.; Vendel, J.

2012-08-01

The French "Institut de Radioprotection et de Sûreté Nucléaire" (IRSN), in support to the French "Autorité de Sûreté Nucléaire", is analysing the safety of ITER fusion installation on the basis of the ITER operator's safety file. IRSN set up a multi-year R&D program in 2007 to support this safety assessment process. Priority has been given to four technical issues and the main outcomes of the work done in 2010 and 2011 are summarized in this paper: for simulation of accident scenarios in the vacuum vessel, adaptation of the ASTEC system code; for risk of explosion of gas-dust mixtures in the vacuum vessel, adaptation of the TONUS-CFD code for gas distribution, development of DUST code for dust transport, and preparation of IRSN experiments on gas inerting, dust mobilization, and hydrogen-dust mixtures explosion; for evaluation of the efficiency of the detritiation systems, thermo-chemical calculations of tritium speciation during transport in the gas phase and preparation of future experiments to evaluate the most influent factors on detritiation; for material neutron activation, adaptation of the VESTA Monte Carlo depletion code. The first results of these tasks have been used in 2011 for the analysis of the ITER safety file. In the near future, this R&D global programme may be reoriented to account for the feedback of the latter analysis or for new knowledge.

OCCUPATIONAL SAFETY AND HEALTH EDUCATION AND TRAINING FOR UNDERSERVED POPULATIONS

PubMed Central

O’CONNOR, TOM; FLYNN, MICHAEL; WEINSTOCK, DEBORAH; ZANONI, JOSEPH

2015-01-01

This article presents an analysis of the essential elements of effective occupational safety and health education and training programs targeting under-served communities. While not an exhaustive review of the literature on occupational safety and health training, the paper provides a guide for practitioners and researchers to the key factors they should consider in the design and implementation of training programs for underserved communities. It also addresses issues of evaluation of such programs, with specific emphasis on considerations for programs involving low-literacy and limited-English-speaking workers. PMID:25053607

Occupational safety and health education and training for underserved populations.

PubMed

O'Connor, Tom; Flynn, Michael; Weinstock, Deborah; Zanoni, Joseph

2014-01-01

This article presents an analysis of the essential elements of effective occupational safety and health education and training programs targeting underserved communities. While not an exhaustive review of the literature on occupational safety and health training, the paper provides a guide for practitioners and researchers to the key factors they should consider in the design and implementation of training programs for underserved communities. It also addresses issues of evaluation of such programs, with specific emphasis on considerations for programs involving low-literacy and limited-English-speaking workers.

External validity of a generic safety climate scale for lone workers across different industries and companies.

PubMed

Lee, Jin; Huang, Yueng-hsiang; Robertson, Michelle M; Murphy, Lauren A; Garabet, Angela; Chang, Wen-Ruey

2014-02-01

The goal of this study was to examine the external validity of a 12-item generic safety climate scale for lone workers in order to evaluate the appropriateness of generalized use of the scale in the measurement of safety climate across various lone work settings. External validity evidence was established by investigating the measurement equivalence (ME) across different industries and companies. Confirmatory factor analysis (CFA)-based and item response theory (IRT)-based perspectives were adopted to examine the ME of the generic safety climate scale for lone workers across 11 companies from the trucking, electrical utility, and cable television industries. Fairly strong evidence of ME was observed for both organization- and group-level generic safety climate sub-scales. Although significant invariance was observed in the item intercepts across the different lone work settings, absolute model fit indices remained satisfactory in the most robust step of CFA-based ME testing. IRT-based ME testing identified only one differentially functioning item from the organization-level generic safety climate sub-scale, but its impact was minimal and strong ME was supported. The generic safety climate scale for lone workers reported good external validity and supported the presence of a common feature of safety climate among lone workers. The scale can be used as an effective safety evaluation tool in various lone work situations. Copyright © 2013 Elsevier Ltd. All rights reserved.

Safety Assessment of Multi Purpose Small Payload Rack(MSPR)

NASA Astrophysics Data System (ADS)

Mizutani, Yoshinobu; Takada, Satomi; Murata, Kosei; Ozawa, Daisaku; Kobayashi, Ryoji; Nakamura, Yasuhiro

2010-09-01

We are reporting summary of preliminary safety assessment for Multi Purpose Small Payload Rack(MSPR), which is one of the micro gravity experiment facilities that are being developed for the 2nd phase JEM utilization(JEM: Japanese Experiment Module) that will be launched on H-II Transfer Vehicle(HTV) 2nd flight in 2011. MSPR is used for multi-purpose micro-g experiment providing experimental spaces and work stations. MSPR has three experimental spaces; first, there is a space called Work Volume(WV) with capacity volume of approximately 350 litters, in which multiple resources including electricity, communication, and moving image functions can be used. Within this space, installation of devices can be done by simple, prompt attachment by Velcro and pins with high degree of flexibility. Second, there is Small Experiment Area(SEA), with capacity volume of approximately 70 litters, in which electricity, communication, and moving image functions can also be used in the same way as WV. These spaces protect experiment devices and specimens from contingent loads by the crewmembers. Third, there is Work Bench with area of 0.5 square meters, on which can be used for maintenance, inspection and data operations of installed devices, etc. This bench can be stored in the rack during contingency. Chamber for Combustion Experiment(CCE) that is planned to be installed in WV is a pressure-resistant experimental container that can be used to seal hazardous materials from combustion experiments. This CCE has double sealing design in chamber itself, which resist gas leakage under normal the temperature and pressure. Electricity, communication, moving image function can be used in the same way as WV. JAXA Phase 2 Safety Review Panel(SRP) has been held in April, 2010. For safety analysis of MSPR, hazards were identified based on Fault Tree Analysis methodology and then these hazards were classified into either eight ISS standard-type hazards or eight unique-type hazards that requires special controls based on ISS common safety assessment methodology. Safety evaluation results are reported in the Safety Assessment Report(SAR) 1). Regarding structural failure, unique hazards are especially evaluated considering not only the tolerance for launch load but also load by crewmembers or orbital loads. Regarding electrical shock, electricity design up to secondary power is evaluated in unique hazard from a view point of Electrical design suitable for high voltage(32VDC or more) circuit. Regarding rupture/leakage of pressure system, hazards of fuel supply line, waste line for combustion gas, and pressure system including CCE are evaluated. Also evaluation for contamination due to hazardous gas leakage from CCE is conducted. External propagation of fire from CCE is also evaluated. In this report, we will show the overview of the result of safety assessment and future plan toward critical design phase activity.

Safety Assessment of Dangerous Goods Transport Enterprise Based on the Relative Entropy Aggregation in Group Decision Making Model

PubMed Central

Wu, Jun; Li, Chengbing; Huo, Yueying

2014-01-01

Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises. PMID:25477954

Safety assessment of dangerous goods transport enterprise based on the relative entropy aggregation in group decision making model.

PubMed

Wu, Jun; Li, Chengbing; Huo, Yueying

2014-01-01

Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises.

The development and psychometric evaluation of a safety climate measure for primary care.

PubMed

de Wet, C; Spence, W; Mash, R; Johnson, P; Bowie, P

2010-12-01

Building a safety culture is an important part of improving patient care. Measuring perceptions of safety climate among healthcare teams and organisations is a key element of this process. Existing measurement instruments are largely developed for secondary care settings in North America and many lack adequate psychometric testing. Our aim was to develop and test an instrument to measure perceptions of safety climate among primary care teams in National Health Service for Scotland. Questionnaire development was facilitated through a steering group, literature review, semistructured interviews with primary care team members, a modified Delphi and completion of a content validity index by experts. A cross-sectional postal survey utilising the questionnaire was undertaken in a random sample of west of Scotland general practices to facilitate psychometric evaluation. Statistical methods, including exploratory and confirmatory factor analysis, and Cronbach and Raykov reliability coefficients were conducted. Of the 667 primary care team members based in 49 general practices surveyed, 563 returned completed questionnaires (84.4%). Psychometric evaluation resulted in the development of a 30-item questionnaire with five safety climate factors: leadership, teamwork, communication, workload and safety systems. Retained items have strong factor loadings to only one factor. Reliability coefficients was satisfactory (α = 0.94 and ρ = 0.93). This study is the first stage in the development of an appropriately valid and reliable safety climate measure for primary care. Measuring safety climate perceptions has the potential to help primary care organisations and teams focus attention on safety-related issues and target improvement through educational interventions. Further research is required to explore acceptability and feasibility issues for primary care teams and the potential for organisational benchmarking.

[Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

PubMed

Liu, Huan; Xie, Yanming

2011-10-01

The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

Influence of different safety shoes on gait and plantar pressure: a standardized examination of workers in the automotive industry

PubMed Central

Ochsmann, Elke; Noll, Ulrike; Ellegast, Rolf; Hermanns, Ingo; Kraus, Thomas

2016-01-01

Objective: Working conditions, such as walking and standing on hard surfaces, can increase the development of musculoskeletal complaints. At the interface between flooring and musculoskeletal system, safety shoes may play an important role in the well-being of employees. The aim of this study was to evaluate the effects of different safety shoes on gait and plantar pressure distributions on industrial flooring. Methods: Twenty automotive workers were individually fitted out with three different pairs of safety shoes ( "normal" shoes, cushioned shoes, and midfoot bearing shoes). They walked at a given speed of 1.5 m/s. The CUELA measuring system and shoe insoles were used for gait analysis and plantar pressure measurements, respectively. Statistical analysis was conducted by ANOVA analysis for repeated measures. Results: Walking with cushioned safety shoes or a midfoot bearing safety shoe led to a significant decrease of the average trunk inclination (p<0.005). Furthermore, the average hip flexion angle decreased for cushioned shoes as well as midfoot bearing shoes (p<0.002). The range of motion of the knee joint increased for cushioned shoes. As expected, plantar pressure distributions varied significantly between cushioned or midfoot bearing shoes and shoes without ergonomic components. Conclusion: The overall function of safety shoes is the avoidance of injury in case of an industrial accident, but in addition, safety shoes could be a long-term preventive instrument for maintaining health of the employees' musculoskeletal system, as they are able to affect gait parameters. Further research needs to focus on safety shoes in working situations. PMID:27488038

Influence of different safety shoes on gait and plantar pressure: a standardized examination of workers in the automotive industry.

PubMed

Ochsmann, Elke; Noll, Ulrike; Ellegast, Rolf; Hermanns, Ingo; Kraus, Thomas

2016-09-30

Working conditions, such as walking and standing on hard surfaces, can increase the development of musculoskeletal complaints. At the interface between flooring and musculoskeletal system, safety shoes may play an important role in the well-being of employees. The aim of this study was to evaluate the effects of different safety shoes on gait and plantar pressure distributions on industrial flooring. Twenty automotive workers were individually fitted out with three different pairs of safety shoes ( "normal" shoes, cushioned shoes, and midfoot bearing shoes). They walked at a given speed of 1.5 m/s. The CUELA measuring system and shoe insoles were used for gait analysis and plantar pressure measurements, respectively. Statistical analysis was conducted by ANOVA analysis for repeated measures. Walking with cushioned safety shoes or a midfoot bearing safety shoe led to a significant decrease of the average trunk inclination (p<0.005). Furthermore, the average hip flexion angle decreased for cushioned shoes as well as midfoot bearing shoes (p<0.002). The range of motion of the knee joint increased for cushioned shoes. As expected, plantar pressure distributions varied significantly between cushioned or midfoot bearing shoes and shoes without ergonomic components. The overall function of safety shoes is the avoidance of injury in case of an industrial accident, but in addition, safety shoes could be a long-term preventive instrument for maintaining health of the employees' musculoskeletal system, as they are able to affect gait parameters. Further research needs to focus on safety shoes in working situations.

Nuclear criticality safety assessment of the low level radioactive waste disposal facility trenches

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kahook, S.D.

1994-04-01

Results of the analyses performed to evaluate the possibility of nuclear criticality in the Low Level Radioactive Waste Disposal Facility (LLRWDF) trenches are documented in this report. The studies presented in this document are limited to assessment of the possibility of criticality due to existing conditions in the LLRWDF. This document does not propose nor set limits for enriched uranium (EU) burial in the LLRWDF and is not a nuclear criticality safety evaluation nor analysis. The calculations presented in the report are Level 2 calculations as defined by the E7 Procedure 2.31, Engineering Calculations.

Systems-based accident analysis in the led outdoor activity domain: application and evaluation of a risk management framework.

PubMed

Salmon, P; Williamson, A; Lenné, M; Mitsopoulos-Rubens, E; Rudin-Brown, C M

2010-08-01

Safety-compromising accidents occur regularly in the led outdoor activity domain. Formal accident analysis is an accepted means of understanding such events and improving safety. Despite this, there remains no universally accepted framework for collecting and analysing accident data in the led outdoor activity domain. This article presents an application of Rasmussen's risk management framework to the analysis of the Lyme Bay sea canoeing incident. This involved the development of an Accimap, the outputs of which were used to evaluate seven predictions made by the framework. The Accimap output was also compared to an analysis using an existing model from the led outdoor activity domain. In conclusion, the Accimap output was found to be more comprehensive and supported all seven of the risk management framework's predictions, suggesting that it shows promise as a theoretically underpinned approach for analysing, and learning from, accidents in the led outdoor activity domain. STATEMENT OF RELEVANCE: Accidents represent a significant problem within the led outdoor activity domain. This article presents an evaluation of a risk management framework that can be used to understand such accidents and to inform the development of accident countermeasures and mitigation strategies for the led outdoor activity domain.

Safety Assessment for a Surface Repository in the Chernobyl Exclusion Zone - Methodology for Assessing Disposal under Intervention Conditions - 13476

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haverkamp, B.; Krone, J.; Shybetskyi, I.

The Radioactive Waste Disposal Facility (RWDF) Buryakovka was constructed in 1986 as part of the intervention measures after the accident at Chernobyl NPP (ChNPP). Today, RWDF Buryakovka is still being operated but its maximum capacity is nearly reached. Plans for enlargement of the facility exist since more than 10 years but have not been implemented yet. In the framework of an European Commission Project DBE Technology GmbH prepared a safety analysis report of the facility in its current state (SAR) and a preliminary safety analysis report (PSAR) based on the planned enlargement. Due to its history RWDF Buryakovka does notmore » fully comply with today's best international practices and the latest Ukrainian regulations in this area. The most critical aspects are its inventory of long-lived radionuclides, and the non-existent multi-barrier waste confinement system. A significant part of the project was dedicated, therefore, to the development of a methodology for the safety assessment taking into consideration the facility's special situation and to reach an agreement with all stakeholders involved in the later review and approval procedure of the safety analysis reports. Main aspect of the agreed methodology was to analyze the safety, not strictly based on regulatory requirements but on the assessment of the actual situation of the facility including its location within the Exclusion Zone. For both safety analysis reports, SAR and PSAR, the assessment of the long-term safety led to results that were either within regulatory limits or within the limits allowing for a specific situational evaluation by the regulator. (authors)« less

Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.

PubMed

Rudroju, Neelima; Bansal, Dipika; Talakokkula, Shiva Teja; Gudala, Kapil; Hota, Debasish; Bhansali, Anil; Ghai, Babita

2013-01-01

Anticonvulsants and antidepressants are mostly used in management of painful diabetic neuropathy (PDN). However there are few direct comparisons between drugs of these classes, making evidence-based decision-making in the treatment of painful diabetic neuropathy difficult. This study aimed to perform a network meta-analysis and benefit-risk analysis to evaluate the comparative efficacy and safety of these drugs in PDN treatment. Comparative effectiveness study. Medical Education and Research facility in India. A comprehensive data search was done in PubMed, Cochrane, and Embase up to August 2012. We then systematically reviewed the studies which compared any of 6 drugs for the management of PDN: amitriptyline, duloxetine, gabapentin, pregabalin, valproate, and venlafaxine or any of their combinations. We performed a random-effects network meta-analysis to rank treatments in terms of efficacy and safety. We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively. We also performed benefit-risk analysis, taking efficacy outcome as benefit and safety outcome as risk. Analysis was intention-to-treat. We included 21 published trials in the analysis. Duloxetine, gabapentin, pregabalin, and venlafaxine were shown to be significantly efficacious compared to placebo with odds ratios (OR) of 2.12, 3.98, 2.78, and 4.43, respectively. Amitriptyline (OR: 7.03, 95% confidence interval [CI]: 1.87, 29.05) and duloxetine (OR: 3.26, 95% CI: 1.04, 9.97) caused more withdrawals than gabapentin. The ranking order of efficacy was gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin, duloxetine, amitriptyline, and placebo and the ranking order of safety was placebo, gabapentin, pregabalin, venlafaxine, duloxetine/gabapentin combination, duloxetine, and amitriptyline. Benefit-risk balance favored the order: gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin combination, duloxetine, placebo, and amitriptyline. We could not include valproate in our analysis owing to the lack of studies reporting the dichotomous efficacy and safety outcomes. Gabapentin was found to be most efficacious and amitriptyline to be least safe among the treatments included in the study. Gabapentin showed most favorable balance between efficacy and safety.

Health Monitoring and Evaluation of Long-Span Bridges Based on Sensing and Data Analysis: A Survey

PubMed Central

Zhou, Jianting; Li, Xiaogang; Xia, Runchuan; Yang, Jun; Zhang, Hong

2017-01-01

Aimed at the health monitoring and evaluation of bridges based on sensing technology, the monitoring contents of different structural types of long-span bridges were defined. Then, the definition, classification, selection principle, and installation requirements of the sensors were summarized. The concept was proposed that new adaptable long-life sensors could be developed by new theories and new effects. The principle and methods to select controlled sections and optimize the layout design of measuring points were illustrated. The functional requirements were elaborated on about the acquisition, transmission, processing, and management of sensing information. Some advanced concepts about the method of bridge safety evaluation were demonstrated and technology bottlenecks in the current safety evaluation were also put forward. Ultimately, combined with engineering practices, an application was carried out. The results showed that new, intelligent, and reliable sensor technology would be one of the main future development directions in the long-span bridge health monitoring and evaluation field. Also, it was imperative to optimize the design of the health monitoring system and realize its standardization. Moreover, it is a heavy responsibility to explore new thoughts and new concepts regarding practical bridge safety and evaluation technology. PMID:28300785

Risk assessment of component failure modes and human errors using a new FMECA approach: application in the safety analysis of HDR brachytherapy.

PubMed

Giardina, M; Castiglia, F; Tomarchio, E

2014-12-01

Failure mode, effects and criticality analysis (FMECA) is a safety technique extensively used in many different industrial fields to identify and prevent potential failures. In the application of traditional FMECA, the risk priority number (RPN) is determined to rank the failure modes; however, the method has been criticised for having several weaknesses. Moreover, it is unable to adequately deal with human errors or negligence. In this paper, a new versatile fuzzy rule-based assessment model is proposed to evaluate the RPN index to rank both component failure and human error. The proposed methodology is applied to potential radiological over-exposure of patients during high-dose-rate brachytherapy treatments. The critical analysis of the results can provide recommendations and suggestions regarding safety provisions for the equipment and procedures required to reduce the occurrence of accidental events.

WinDAM C earthen embankment internal erosion analysis software

USDA-ARS?s Scientific Manuscript database

Two primary causes of dam failure are overtopping and internal erosion. For the purpose of evaluating dam safety for existing earthen embankment dams and proposed earthen embankment dams, Windows Dam Analysis Modules C (WinDAM C) software will simulate either internal erosion or erosion resulting f...

Evaluation of the impacts of cooperative adaptive cruise control on reducing rear-end collision risks on freeways.

PubMed

Li, Ye; Wang, Hao; Wang, Wei; Xing, Lu; Liu, Shanwen; Wei, Xueyan

2017-01-01

Although plenty of studies have been conducted recently about the impacts of cooperative adaptive cruise control (CACC) system on traffic efficiency, there are few researches analyzing the safety effects of this advanced driving-assistant system. Thus, the primary objective of this study is to evaluate the impacts of the CACC system on reducing rear-end collision risks on freeways. The CACC model is firstly developed, which is based on the Intelligent Driver Model (IDM). Then, two surrogated safety measures, derived from the time-to-collision (TTC), denoting time exposed time-to-collision (TET) and time integrated time-to-collision (TIT), are introduced for quantifying the collision risks. And the safety effects are analyzed both theoretically and experimentally, by the linear stability analysis and simulations. The theoretical and simulation results conformably indicate that the CACC system brings dramatic benefits for reducing rear-end collision risks (TET and TIT are reduced more than 90%, respectively), when the desired time headway and time delay are set properly. The sensitivity analysis indicates there are few differences among different values of the threshold of TTC and the length of a CACC platoon. The results also show that the safety improvements weaken with the decrease of the penetration rates of CACC on the market and the increase of time delay between platoons. We also evaluate the traffic efficiency of the CACC system with different desired time headway. Copyright © 2016 Elsevier Ltd. All rights reserved.

Long-term impact of community-based information, education and communication activities on food hygiene and food safety behaviors in Vietnam: a longitudinal study.

PubMed

Takanashi, Kumiko; Quyen, Dao To; Le Hoa, Nguyen Thi; Khan, Nguyen Cong; Yasuoka, Junko; Jimba, Masamine

2013-01-01

Ingestion of contaminated water or food is a major contributor to childhood diarrhea in developing countries. In Vietnam, the use of community-based information, education and communication (IEC) activities could be a sustainable strategy to improve food hygiene and food safety behaviors. This study thus examined the long-term impact of community-based IEC activities on food hygiene and food safety behaviors. In this longitudinal study, we interviewed caregivers of children aged between six months and four years in suburban Hanoi. Baseline data were collected in January 2006 (n = 125). After conducting IEC interventions, we collected a 1(st) set of evaluation data in January 2007 (n = 132). To examine the long-term impact of the interventions, we then collected a 2(nd) set of evaluation data in January 2008 (n = 185). Changes in childhood diarrhea prevalence, IEC coverage, and food hygiene and food safety behaviors were assessed over a two-year period using bivariate and logistic regression analyses. Effective IEC channels were determined through multiple linear regression analysis. Childhood diarrhea was significantly reduced from 21.6% at baseline to 7.6% at the 1(st) post-intervention evaluation (P = 0.002), and to 5.9% at the 2(nd) evaluation. Among 17 food hygiene and food safety behaviors measured, a total of 11 behaviors were improved or maintained by the 2(nd) evaluation. Handwashing after toilet use was significantly improved at both evaluation points. Overall, 3 food safety behaviors and 7 food hygiene behaviors were found to have significantly improved at the 1(st) and at the 2(nd) evaluations, respectively. Flip chart communication administered by community groups was identified to be the most effective IEC channel for effecting behavior change (P = 0.018). Flip chart communication administered by community groups is effective for improving multiple food hygiene and food safety behaviors in sustainable ways, and should be included in water and health promotion programs.

Process value of care safety: women's willingness to pay for perinatal services.

PubMed

Anezaki, Hisataka; Hashimoto, Hideki

2017-08-01

To evaluate the process value of care safety from the patient's view in perinatal services. Cross-sectional survey. Fifty two sites of mandated public neonatal health checkup in 6 urban cities in West Japan. Mothers who attended neonatal health checkups for their babies in 2011 (n = 1316, response rate = 27.4%). Willingness to pay (WTP) for physician-attended care compared with midwife care as the process-related value of care safety. WTP was estimated using conjoint analysis based on the participants' choice over possible alternatives that were randomly assigned from among eight scenarios considering attributes such as professional attendance, amenities, painless delivery, caesarean section rate, travel time and price. The WTP for physician-attended care over midwife care was estimated 1283 USD. Women who had experienced complications in prior deliveries had a 1.5 times larger WTP. We empirically evaluated the process value for safety practice in perinatal care that was larger than a previously reported accounting-based value. Our results indicate that measurement of process value from the patient's view is informative for the evaluation of safety care, and that it is sensitive to individual risk perception for the care process. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

PubMed Central

Schweizer, Anja; Dejager, Sylvie; Foley, James E; Kothny, Wolfgang

2011-01-01

Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials. Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks’ duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths. Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas. Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies. PMID:21415917

Swedish translation and psychometric testing of the safety attitudes questionnaire (operating room version).

PubMed

Göras, Camilla; Wallentin, Fan Yang; Nilsson, Ulrica; Ehrenberg, Anna

2013-03-19

Tens of millions of patients worldwide suffer from avoidable disabling injuries and death every year. Measuring the safety climate in health care is an important step in improving patient safety. The most commonly used instrument to measure safety climate is the Safety Attitudes Questionnaire (SAQ). The aim of the present study was to establish the validity and reliability of the translated version of the SAQ. The SAQ was translated and adapted to the Swedish context. The survey was then carried out with 374 respondents in the operating room (OR) setting. Data was received from three hospitals, a total of 237 responses. Cronbach's alpha and confirmatory factor analysis (CFA) was used to evaluate the reliability and validity of the instrument. The Cronbach's alpha values for each of the factors of the SAQ ranged between 0.59 and 0.83. The CFA and its goodness-of-fit indices (SRMR 0.055, RMSEA 0.043, CFI 0.98) showed good model fit. Intercorrelations between the factors safety climate, teamwork climate, job satisfaction, perceptions of management, and working conditions showed moderate to high correlation with each other. The factor stress recognition had no significant correlation with teamwork climate, perception of management, or job satisfaction. Therefore, the Swedish translation and psychometric testing of the SAQ (OR version) has good construct validity. However, the reliability analysis suggested that some of the items need further refinement to establish sound internal consistency. As suggested by previous research, the SAQ is potentially a useful tool for evaluating safety climate. However, further psychometric testing is required with larger samples to establish the psychometric properties of the instrument for use in Sweden.

Subjective safety and self-confidence in prehospital trauma care and learning progress after trauma-courses: part of the prospective longitudinal mixed-methods EPPTC-trial.

PubMed

Häske, David; Beckers, Stefan K; Hofmann, Marzellus; Lefering, Rolf; Grützner, Paul A; Stöckle, Ulrich; Papathanassiou, Vassilios; Münzberg, Matthias

2017-08-14

Prehospital trauma care is stressful and requires multi-professional teamwork. A decrease in the number of accident victims ultimately affects the routine and skills and underlines the importance of effective training. Standardized courses, like PHTLS, are established for health care professionals to improve the prehospital care of trauma patients. The aim of the study was to investigate the subjective safety in prehospital trauma care and learning progress by paramedics in a longitudinal analysis. This was a prospective intervention trial and part of the mixed-method longitudinal EPPTC-trial, evaluating subjective and objective changes among participants and real patient care as a result of PHTLS courses. Participants were evaluated with pre/post questionnaires as well as one year after the course. We included 236 datasets. In the pre/post comparison, an increased performance could be observed in nearly all cases. The result shows that the expectations of the participants of the course were fully met even after one year (p = 0.002). The subjective safety in trauma care is significantly better even one year after the course (p < 0.001). Regression analysis showed that (ABCDE)-structure is decisive (p = 0.036) as well as safety in rare and common skills (both p < 0.001). Most skills are also rated better after one year. Knowledge and specific safety are assessed as worse after one year. The courses meet the expectations of the participants and increase the subjective safety in the prehospital care of trauma patients. ABCDE-structure and safety in skills are crucial. In the short term, both safety in skills and knowledge can be increased, but the courses do not have the power to maintain knowledge and specific subjective safety issues over a year. German Clinical Trials Register, ID DRKS00004713 , registered 14. February 2014.

Did you have an impact? A theory-based method for planning and evaluating knowledge-transfer and exchange activities in occupational health and safety.

PubMed

Kramer, Desré M; Wells, Richard P; Carlan, Nicolette; Aversa, Theresa; Bigelow, Philip P; Dixon, Shane M; McMillan, Keith

2013-01-01

Few evaluation tools are available to assess knowledge-transfer and exchange interventions. The objective of this paper is to develop and demonstrate a theory-based knowledge-transfer and exchange method of evaluation (KEME) that synthesizes 3 theoretical frameworks: the promoting action on research implementation of health services (PARiHS) model, the transtheoretical model of change, and a model of knowledge use. It proposes a new term, keme, to mean a unit of evidence-based transferable knowledge. The usefulness of the evaluation method is demonstrated with 4 occupational health and safety knowledge transfer and exchange (KTE) implementation case studies that are based upon the analysis of over 50 pre-existing interviews. The usefulness of the evaluation model has enabled us to better understand stakeholder feedback, frame our interpretation, and perform a more comprehensive evaluation of the knowledge use outcomes of our KTE efforts.

Does lean management improve patient safety culture? An extensive evaluation of safety culture in a radiotherapy institute.

PubMed

Simons, Pascale A M; Houben, Ruud; Vlayen, Annemie; Hellings, Johan; Pijls-Johannesma, Madelon; Marneffe, Wim; Vandijck, Dominique

2015-02-01

The importance of a safety culture to maximize safety is no longer questioned. However, achieving sustainable culture improvements are less evident. Evidence is growing for a multifaceted approach, where multiple safety interventions are combined. Lean management is such an integral approach to improve safety, quality and efficiency and therefore, could be expected to improve the safety culture. This paper presents the effects of lean management activities on the patient safety culture in a radiotherapy institute. Patient safety culture was evaluated over a three year period using triangulation of methodologies. Two surveys were distributed three times, workshops were performed twice, data from an incident reporting system (IRS) was monitored and results were explored using structured interviews with professionals. Averages, chi-square, logistical and multi-level regression were used for analysis. The workshops showed no changes in safety culture, whereas the surveys showed improvements on six out of twelve dimensions of safety climate. The intention to report incidents not reaching patient-level decreased in accordance with the decreasing number of reports in the IRS. However, the intention to take action in order to prevent future incidents improved (factorial survey presented β: 1.19 with p: 0.01). Due to increased problem solving and improvements in equipment, the number of incidents decreased. Although the intention to report incidents not reaching patient-level decreased, employees experienced sustained safety awareness and an increased intention to structurally improve. The patient safety culture improved due to the lean activities combined with an organizational restructure, and actual patient safety outcomes might have improved as well. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Efficacy and Safety of Mainstream Medications for Patients With cDMARD-Naïve Rheumatoid Arthritis: A Network Meta-Analysis.

PubMed

Cai, Weiyan; Gu, Youyi; Cui, Huanqin; Cao, Yinyin; Wang, Xiaoliang; Yao, Yi; Wang, Mingyu

2018-01-01

Background: The mainstream medications for rheumatoid arthritis (RA) include conventional disease-modifying antirheumatic drugs (cDMARDs), which mostly are methotrexate (MTX), and biologic agents such as adalimumab (ADA), certolizumab (CZP), etanercept (ETN), golimumab (GOL), infliximab (IFX), and tocilizumab (TCZ). This network meta-analysis was aimed at evaluating the efficacy and safety of the medications above and interventions combining cDMARDs and biologic agents for patients with RA. Methods: PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov were searched systematically for eligible randomized controlled trials (RCTs). Outcomes concerning efficacy and safety were evaluated utilizing odds ratios (ORs) and 95% credible intervals ( CrI ). The outcomes of efficacy would be evaluated through remission and American College of Rheumatology (ACR) scores. The surface under the cumulative ranking curve (SUCRA) was calculated to rank each treatment on each index. Results: A total of 20 RCTs with 9,047 patients were included, and the efficacy and safety of the concerning interventions for RA were evaluated. Compared with cDMARDs alone, TCZ+MTX, ETN+MTX, IFX+MTX, TCZ, and ADA+MTX showed significant statistical advantage on ACR20, ACR50, and ACR70. Apart from that, as for remission, TCZ+MTX, IFX+MTX, TCZ, and CZP+MTX performed better compared to cDMARDs alone. The SUCRA ranking also indicated that TCZ+MTX was the intervention with best ranking in the entire four efficacy indexes followed by ETX+MTX and IFX+MTX. However, there was no obvious difference among these medications compared with cDMARDs when it comes to safety, which need more specific studies on that. Conclusion: TCZ+MTX was potentially the most recommended combination of medications for RA due to its good performance in all outcomes of efficacy. ETX+MTX and IFX+MTX, which also performed well, could be introduced as alternative treatments. However, considering the adverse events, the treatments concerning should be introduced with caution.

An evaluation of costs and benefits of a vehicle periodic inspection scheme with six-monthly inspections compared to annual inspections.

PubMed

Keall, Michael D; Newstead, Stuart

2013-09-01

Although previous research suggests that safety benefits accrue from periodic vehicle inspection programmes, little consideration has been given to whether the benefits are sufficient to justify the often considerable costs of such schemes. Methodological barriers impede many attempts to evaluate the overall safety benefits of periodic vehicle inspection schemes, including this study, which did not attempt to evaluate the New Zealand warrant of fitness scheme as a whole. Instead, this study evaluated one aspect of the scheme: the effects of doubling the inspection frequency, from annual to biannual, when the vehicle reaches six years of age. In particular, reductions in safety-related vehicle faults were estimated together with the value of the safety benefits compared to the costs. When merged crash data, licensing data and roadworthiness inspection data were analysed, there were estimated to be improvements in injury crash involvement rates and prevalence of safety-related faults of respectively 8% (95% CI 0.4-15%) and 13.5% (95% CI 12.8-14.2%) associated with the increase from annual to 6-monthly inspections. The wide confidence interval for the drop in crash rate shows considerably statistical uncertainty about the precise size of the drop. Even assuming that this proportion of vehicle faults prevented by doubling the inspection frequency could be maintained over the vehicle age range 7-20 years, the safety benefits are very unlikely to exceed the additional costs of the 6-monthly inspections to the motorists, valued at $NZ 500 million annually excluding the overall costs of administering the scheme. The New Zealand warrant of fitness scheme as a whole cannot be robustly evaluated using the analysis approach used here, but the safety benefits would need to be substantial--yielding an unlikely 12% reduction in injury crashes--for benefits to equal costs. Copyright © 2013 Elsevier Ltd. All rights reserved.

Safety leadership and systems thinking: application and evaluation of a Risk Management Framework in the mining industry.

PubMed

Donovan, Sarah-Louise; Salmon, Paul M; Lenné, Michael G; Horberry, Tim

2017-10-01

Safety leadership is an important factor in supporting safety in high-risk industries. This article contends that applying systems-thinking methods to examine safety leadership can support improved learning from incidents. A case study analysis was undertaken of a large-scale mining landslide incident in which no injuries or fatalities were incurred. A multi-method approach was adopted, in which the Critical Decision Method, Rasmussen's Risk Management Framework and Accimap method were applied to examine the safety leadership decisions and actions which enabled the safe outcome. The approach enabled Rasmussen's predictions regarding safety and performance to be examined in the safety leadership context, with findings demonstrating the distribution of safety leadership across leader and system levels, and the presence of vertical integration as key to supporting the successful safety outcome. In doing so, the findings also demonstrate the usefulness of applying systems-thinking methods to examine and learn from incidents in terms of what 'went right'. The implications, including future research directions, are discussed. Practitioner Summary: This paper presents a case study analysis, in which systems-thinking methods are applied to the examination of safety leadership decisions and actions during a large-scale mining landslide incident. The findings establish safety leadership as a systems phenomenon, and furthermore, demonstrate the usefulness of applying systems-thinking methods to learn from incidents in terms of what 'went right'. Implications, including future research directions, are discussed.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Poncio, S.; Adkison, P.

Coating costs are escalating due to increased awareness of the environment and safety and health issues. Owners can reduce the overall cost of maintenance painting projects through the implementation of a total quality program. This program should encompass project pre-planning, evaluation of safety and quality assurance programs, and analysis of employee absenteeism and turnover. The information presented is a case history of one utility's experience managing a maintenance painting program during a five-year period.

An Analysis of the Role of Social Safety Net Scholarships in Reducing School Drop-Out during the Indonesian Economic Crisis. Innocenti Working Papers.

ERIC Educational Resources Information Center

Cameron, Lisa A.

This paper uses regression and matching techniques to evaluate Indonesia's Social Safety Net Scholarships Programme. The scholarships program was developed to try to prevent large numbers of children from dropping out of school as a result of the Asian financial crisis. The expectation was that many families would find it difficult to keep their…

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients.

PubMed

Api, A M; Belsito, D; Bruze, M; Cadby, P; Calow, P; Dagli, M L; Dekant, W; Ellis, G; Fryer, A D; Fukayama, M; Griem, P; Hickey, C; Kromidas, L; Lalko, J F; Liebler, D C; Miyachi, Y; Politano, V T; Renskers, K; Ritacco, G; Salvito, D; Schultz, T W; Sipes, I G; Smith, B; Vitale, D; Wilcox, D K

2015-08-01

The Research Institute for Fragrance Materials, Inc. (RIFM) has been engaged in the generation and evaluation of safety data for fragrance materials since its inception over 45 years ago. Over time, RIFM's approach to gathering data, estimating exposure and assessing safety has evolved as the tools for risk assessment evolved. This publication is designed to update the RIFM safety assessment process, which follows a series of decision trees, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past ten years. These changes include incorporating 1) new scientific information including a framework for choosing structural analogs, 2) consideration of the Threshold of Toxicological Concern (TTC), 3) the Quantitative Risk Assessment (QRA) for dermal sensitization, 4) the respiratory route of exposure, 5) aggregate exposure assessment methodology, 6) the latest methodology and approaches to risk assessments, 7) the latest alternatives to animal testing methodology and 8) environmental risk assessment. The assessment begins with a thorough analysis of existing data followed by in silico analysis, identification of 'read across' analogs, generation of additional data through in vitro testing as well as consideration of the TTC approach. If necessary, risk management may be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Results of a post-marketing surveillance of meropenem administered over 2 g/day for serious infectious diseases].

PubMed

Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

2015-10-01

The post-marketing surveillance of meropenem (Meropen®) administered over 2g/day for serious infectious diseases was conducted between August 2011 and June 2013 to evaluate safety and efficacy under actual clinical use. There were 382 and 322 evaluable cases for safety and efficacy respectively, of 399 case cards collected from 87 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 19.1% (73/382 cases), and the main ADRs were hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, liver disorder, and diarrhoea, which were similar to these observed in the post-marketing surveillances of meropenem conducted before. In efficacy analysis, the efficacy was 73.6% (237/322 cases), which is as same as 71.4% (3214/4504 cases) of post-marketing surveillance of meropenem conducted after first approval under 2 g/day for infectious diseases. These results confirmed meropenem (Meropen®) is one of the useful antimicrobial agents for serious infectious diseases.

Guidance on health effects of toxic chemicals. Safety Analysis Report Update Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Foust, C.B.; Griffin, G.D.; Munro, N.B.

1994-02-01

Martin Marietta Energy Systems, Inc. (MMES), and Martin Marietta Utility Services, Inc. (MMUS), are engaged in phased programs to update the safety documentation for the existing US Department of Energy (DOE)-owned facilities. The safety analysis of potential toxic hazards requires a methodology for evaluating human health effects of predicted toxic exposures. This report provides a consistent set of health effects and documents toxicity estimates corresponding to these health effects for some of the more important chemicals found within MMES and MMUS. The estimates are based on published toxicity information and apply to acute exposures for an ``average`` individual. The healthmore » effects (toxicological endpoints) used in this report are (1) the detection threshold; (2) the no-observed adverse effect level; (3) the onset of irritation/reversible effects; (4) the onset of irreversible effects; and (5) a lethal exposure, defined to be the 50% lethal level. An irreversible effect is defined as a significant effect on a person`s quality of life, e.g., serious injury. Predicted consequences are evaluated on the basis of concentration and exposure time.« less

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

PubMed

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

Comprehensive assessment of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis

PubMed Central

Valeyre, Dominique; Albera, Carlo; Bradford, Williamson Z; Costabel, Ulrich; King, Talmadge E; Leff, Jonathan A; Noble, Paul W; Sahn, Steven A; du Bois, Roland M

2014-01-01

Background and objective Pirfenidone is an oral antifibrotic agent that is approved in several countries for the treatment of idiopathic pulmonary fibrosis (IPF). We performed a comprehensive analysis of safety across four clinical trials evaluating pirfenidone in patients with IPF. Methods All patients receiving pirfenidone 2403 mg/day in the Phase 3 CAPACITY studies (Studies 004 and 006) and all patients receiving at least one dose of pirfenidone in one of two ongoing open-label studies in patients with IPF (Studies 002 and 012) were selected for inclusion. Safety outcomes were evaluated from baseline until 28 days after the last dose of study drug. Results A total of 789 patients were included in the analysis. The median duration of exposure to pirfenidone was 2.6 years (range, 1 week–7.7 years), and the cumulative total exposure was 2059 person exposure years (PEY). Gastrointestinal and skin-related events were the most commonly reported adverse events; these were almost always mild to moderate in severity, and rarely led to treatment discontinuation. Elevations (>3× upper limit of normal) in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) occurred in 21/789 (2.7%) patients; the adjusted incidence of AST/ALT elevations was 1.7 per 100 PEY. Conclusions This comprehensive analysis of safety in a large cohort of IPF patients receiving pirfenidone for a total of 2059 PEY demonstrates that long-term treatment with pirfenidone is safe and generally well tolerated. PMID:24836849

Occupational Safety Precautions among Nurses at Four Hospitals, Nablus District, Palestine.

PubMed

Al-Khatib, I A; El Ansari, W; Areqat, T A; Darkhawaja, R A; Mansour, S H; Tucktuck, M A; Khatib, J I

2015-10-01

Occupational hazards, exposure to blood and body fluids (BBF) accidents and safety precautions constitute an important public health issue. We assessed the prevalence and determinants of exposure to occupational hazards among nurses, and their knowledge of occupational safety precautions. In a cross-sectional study, we surveyed 332 nurses working in 4 hospitals, Nablus, West Bank, Palestine, by a questionnaire. Bivariate analysis tested the associations between ever exposure and the high likelihood of BBF exposure and the independent socio-demographic and occupational variables. Binary logistic regression analysis was used to assess the associations between the same two exposures and selected independent variables (those significant in the bivariate analysis). Prevalence of ever exposure to BBF was 51.7%, and was associated with working in private and charitable hospitals (OR 2.62, 2.68, respectively), having 4-6 family members (OR 0.52) and "nursing" being as one's top career choice at university (OR 0.48). The prevalence of high likelihood of BBF exposure was 62.2%, and was associated with working in charitable and private hospitals (OR 7.81, 2.43, respectively) and "nursing" being as one's top career choice (OR 0.57). Regarding knowledge, most respondents believed it is necessary to enact laws and regulations regarding occupational safety precautions, reported the use of sharps containers, immediate disinfection after an accident, reporting an accident, and using personal protective equipment. Nurses had adequate knowledge of the risks of their hospital work. Nevertheless, they exhibited high prevalence of exposure to BBF accidents. Future studies are needed to re-evaluate existing occupational safety guidelines in hospitals, establish monitoring and evaluation protocols for health care workers' adherence to the guidelines, and institute well-defined policies for reporting occupational injury incidents so these can be handled appropriately.

Quantitative assessment of building fire risk to life safety.

PubMed

Guanquan, Chu; Jinhua, Sun

2008-06-01

This article presents a quantitative risk assessment framework for evaluating fire risk to life safety. Fire risk is divided into two parts: probability and corresponding consequence of every fire scenario. The time-dependent event tree technique is used to analyze probable fire scenarios based on the effect of fire protection systems on fire spread and smoke movement. To obtain the variation of occurrence probability with time, Markov chain is combined with a time-dependent event tree for stochastic analysis on the occurrence probability of fire scenarios. To obtain consequences of every fire scenario, some uncertainties are considered in the risk analysis process. When calculating the onset time to untenable conditions, a range of fires are designed based on different fire growth rates, after which uncertainty of onset time to untenable conditions can be characterized by probability distribution. When calculating occupant evacuation time, occupant premovement time is considered as a probability distribution. Consequences of a fire scenario can be evaluated according to probability distribution of evacuation time and onset time of untenable conditions. Then, fire risk to life safety can be evaluated based on occurrence probability and consequences of every fire scenario. To express the risk assessment method in detail, a commercial building is presented as a case study. A discussion compares the assessment result of the case study with fire statistics.

Are measurements of patient safety culture and adverse events valid and reliable? Results from a cross sectional study.

PubMed

Farup, Per G

2015-05-02

The association between measurements of the patient safety culture and the "true" patient safety has been insufficiently documented, and the validity of the tools used for the measurements has been questioned. This study explored associations between the patient safety culture and adverse events, and evaluated the validity of the tools. In 2008/2009, a survey on patient safety culture was performed with Hospital Survey on Patient Safety Culture (HSOPSC) in two medical departments in two geographically separated hospitals of Innlandet Hospital Trust. Later, a retrospective analysis of adverse events during the same period was performed with the Global Trigger Tool (GTT). The safety culture and adverse events were compared between the departments. 185 employees participated in the study, and 272 patient records were analysed. The HSOPSC scores were lower and adverse events less prevalent in department 1 than in department 2. In departments 1 and 2 the mean HSOPSC scores (SD) were at the unit level 3.62 (0.42) and 3.90 (0.37) (p < 0.001), and at the hospital level 3.35 (1.53) and 3.67 (0.53) (ns, p = 0.19) respectively. The proportion of records with adverse events were 10/135 (7%) and 28/137 (20%) (p = 0.003) respectively. There was an inverse association between the patient safety culture and adverse events. Until the criterion validity of the tools for measuring patient safety culture and tracking of adverse events have been further evaluated, measurement of patient safety culture could not be used as a proxy for the "true" safety.

Prospective clinical evaluation of the Polyperf® Safe, a safety Huber needle, in cancer patients.

PubMed

Goossens, Godelieve A; Moons, Philip; Jérôme, Martine; Stas, Marguerite

2011-01-01

Evaluation of the Polyperf® Safe (PPS) needle on safety and user-friendliness, as experienced by first-time and non-first-time users of the device. A prospective, descriptive study was carried out at the University Hospitals Leuven, Belgium. Five hundred PPS needles were individually evaluated in cancer patients. Different aspects of the PPS were assessed: packaging, needle insertion, and needle removal. Nurses were asked whether they had previously inserted or removed this type of needle. We compared the PPS needle with the standard Gripper® needle in terms of safety, ease of use, and ease of training. Three hundred sixty-six evaluation forms were available for analysis (73.2%). Packaging and access evaluations were scored positively, except for two aspects: (1) needle stability, and (2) ease of dressing. Ease of removal was scored unsatisfactory in up to 22.4% of the registrations. Pain at insertion was reported in about 20% registrations, and blood contact was reported by 2.5% of non-first-time users. Safety was scored as good, although ease of use and ease in training scored 25.4% and 43.8%, respectively, lower than the Gripper®. In general, nurses evaluated the PPS positively, with the exception of needle stability, ease of dressing, and ease of removal. No needlestick accidents were recorded. Aspects of ease of use and ease of training for PPS needles scored less than those for the Gripper® needles in up to one-third of the registrations.

Regulatory Science in Professional Education.

PubMed

Akiyama, Hiroshi

2017-01-01

In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

Pavement, bridge, and safety cost evaluation tool for overweight truck corridors serving coastal port regions and border ports of entry

DOT National Transportation Integrated Search

2017-08-01

To address the need for a rational but fast method to determine costs and a proposed permit fee, the research team developed the Stage 1 Expedient Analysis Method. The method was used to evaluate potential oversize/overweight (OS/OW) freight corridor...

Electrical deaths in the US construction: an analysis of fatality investigations.

PubMed

Zhao, Dong; Thabet, Walid; McCoy, Andrew; Kleiner, Brian

2014-01-01

Electrocution is among the 'fatal four' in US construction according to the Occupational Safety and Health Administration. Learning from failures is believed to be an effective path to success, with deaths being the most serious system failures. This paper examined the failures in electrical safety by analysing all electrical fatality investigations (N = 132) occurring between 1989 and 2010 from the Fatality Assessment and Control Evaluation programme that is completed by the National Institute of Occupational Safety and Health. Results reveal the features of the electrical fatalities in construction and disclose the most common electrical safety challenges on construction sites. This research also suggests the sociotechnical system breakdowns and the less effectiveness of current safety training programmes may significantly contribute to worker's unsafe behaviours and electrical fatality occurrences.

Using the electronic health record to build a culture of practice safety: evaluating the implementation of trigger tools in one general practice.

PubMed

Margham, Tom; Symes, Natalie; Hull, Sally A

2018-04-01

Identifying patients at risk of harm in general practice is challenging for busy clinicians. In UK primary care, trigger tools and case note reviews are mainly used to identify rates of harm in sample populations. This study explores how adaptions to existing trigger tool methodology can identify patient safety events and engage clinicians in ongoing reflective work around safety. Mixed-method quantitative and narrative evaluation using thematic analysis in a single East London training practice. The project team developed and tested five trigger searches, supported by Excel worksheets to guide the case review process. Project evaluation included summary statistics of completed worksheets and a qualitative review focused on ease of use, barriers to implementation, and perception of value to clinicians. Trigger searches identified 204 patients for GP review. Overall, 117 (57%) of cases were reviewed and 62 (53%) of these cases had patient safety events identified. These were usually incidents of omission, including failure to monitor or review. Key themes from interviews with practice members included the fact that GPs' work is generally reactive and GPs welcomed an approach that identified patients who were 'under the radar' of safety. All GPs expressed concern that the tool might identify too many patients at risk of harm, placing further demands on their time. Electronic trigger tools can identify patients for review in domains of clinical risk for primary care. The high yield of safety events engaged clinicians and provided validation of the need for routine safety checks. © British Journal of General Practice 2018.

Innovative neuro-fuzzy system of smart transport infrastructure for road traffic safety

NASA Astrophysics Data System (ADS)

Beinarovica, Anna; Gorobetz, Mikhail; Levchenkov, Anatoly

2017-09-01

The proposed study describes applying of neural network and fuzzy logic in transport control for safety improvement by evaluation of accidents’ risk by intelligent infrastructure devices. Risk evaluation is made by following multiple-criteria: danger, changeability and influence of changes for risk increasing. Neuro-fuzzy algorithms are described and proposed for task solution. The novelty of the proposed system is proved by deep analysis of known studies in the field. The structure of neuro-fuzzy system for risk evaluation and mathematical model is described in the paper. The simulation model of the intelligent devices for transport infrastructure is proposed to simulate different situations, assess the risks and propose the possible actions for infrastructure or vehicles to minimize the risk of possible accidents.

Criticality Safety Evaluation Report CSER-96-019 for Spent Nuclear Fuel (SNF) Processing and Storage Facilities Multi Canister Overpack (MCO)

DOE Office of Scientific and Technical Information (OSTI.GOV)

KESSLER, S.F.

This criticality evaluation is for Spent N Reactor fuel unloaded from the existing canisters in both KE and KW Basins, and loaded into multiple canister overpack (MCO) containers with specially built baskets containing a maximum of either 54 Mark IV or 48 Mark IA fuel assemblies. The criticality evaluations include loading baskets into the cask-MCO, operation at the Cold Vacuum Drying Facility,a nd storage in the Canister Storage Building. Many conservatisms have been built into this analysis, the primary one being the selection of the K{sub eff} = 0.95 criticality safety limit. This revision incorporates the analyses for the sampling/weldmore » station in the Canister Storage Building and additional analysis of the MCO during the draining at CVDF. Additional discussion of the scrap basket model was added to show why the addition of copper divider plates was not included in the models.« less

An empirical Bayes safety evaluation of tram/streetcar signal and lane priority measures in Melbourne.

PubMed

Naznin, Farhana; Currie, Graham; Sarvi, Majid; Logan, David

2016-01-01

Streetcars/tram systems are growing worldwide, and many are given priority to increase speed and reliability performance in mixed traffic conditions. Research related to the road safety impact of tram priority is limited. This study explores the road safety impacts of tram priority measures including lane and intersection/signal priority measures. A before-after crash study was conducted using the empirical Bayes (EB) method to provide more accurate crash impact estimates by accounting for wider crash trends and regression to the mean effects. Before-after crash data for 29 intersections with tram signal priority and 23 arterials with tram lane priority in Melbourne, Australia, were analyzed to evaluate the road safety impact of tram priority. The EB before-after analysis results indicated a statistically significant adjusted crash reduction rate of 16.4% after implementation of tram priority measures. Signal priority measures were found to reduce crashes by 13.9% and lane priority by 19.4%. A disaggregate level simple before-after analysis indicated reductions in total and serious crashes as well as vehicle-, pedestrian-, and motorcycle-involved crashes. In addition, reductions in on-path crashes, pedestrian-involved crashes, and collisions among vehicles moving in the same and opposite directions and all other specific crash types were found after tram priority implementation. Results suggest that streetcar/tram priority measures result in safety benefits for all road users, including vehicles, pedestrians, and cyclists. Policy implications and areas for future research are discussed.

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

PubMed

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-01-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

PubMed

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-04-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

[Evaluating training programs on occupational health and safety: questionnaire development].

PubMed

Zhou, Xiao-Yan; Wang, Zhi-Ming; Wang, Mian-Zhen

2006-03-01

To develop a questionnaire to evaluate the quality of training programs on occupational health and safety. A questionnaire comprising five subscales and 21 items was developed. The reliability and validity of the questionnaire was tested. Final validation of the questionnaire was undertaken in 700 workers in an oil refining company. The Cronbach's alpha coefficients of the five subscales ranged from 0.6194 to 0.6611. The subscale-scale Pearson correlation coefficients ranged from 0.568 to 0.834 . The theta coefficients of the five subscales were greater than 0.7. The factor loadings of the five subscales in the principal component analysis ranged from 0.731 to 0.855. Use of the questionnaire in the 700 workers produced a good discriminability, with excellent, good, fair and poor comprising 22.2%, 31.2%, 32.4% and 14.1 respectively. Given the fact that 18.7% of workers had never been trained and 29.7% of workers got one-off training only, the training program scored an average of 57.2. The questionnaire is suitable to be used in evaluating the quality of training programs on occupational health and safety. The oil refining company needs to improve training for their workers on occupational health and safety.

Evaluating the safety impact of adaptive cruise control in traffic oscillations on freeways.

PubMed

Li, Ye; Li, Zhibin; Wang, Hao; Wang, Wei; Xing, Lu

2017-07-01

Adaptive cruise control (ACC) has been considered one of the critical components of automated driving. ACC adjusts vehicle speeds automatically by measuring the status of the ego-vehicle and leading vehicle. Current commercial ACCs are designed to be comfortable and convenient driving systems. Little attention is paid to the safety impacts of ACC, especially in traffic oscillations when crash risks are the highest. The primary objective of this study was to evaluate the impacts of ACC parameter settings on rear-end collisions on freeways. First, the occurrence of a rear-end collision in a stop-and-go wave was analyzed. A car-following model in an integrated ACC was developed for a simulation analysis. The time-to-collision based factors were calculated as surrogate safety measures of the collision risk. We also evaluated different market penetration rates considering that the application of ACC will be a gradual process. The results showed that the safety impacts of ACC were largely affected by the parameters. Smaller time delays and larger time gaps improved safety performance, but inappropriate parameter settings increased the collision risks and caused traffic disturbances. A higher reduction of the collision risk was achieved as the ACC vehicle penetration rate increased, especially in the initial stage with penetration rates of less than 30%. This study also showed that in the initial stage, the combination of ACC and a variable speed limit achieved better safety improvements on congested freeways than each single technique. Copyright © 2017 Elsevier Ltd. All rights reserved.

Direct oral anticoagulants for extended thromboprophylaxis in medically ill patients: meta-analysis and risk/benefit assessment.

PubMed

Al Yami, Majed S; Kurdi, Sawsan; Abraham, Ivo

2018-01-01

Standard-duration (7-10 days) thromboprophylaxis with low molecular weight heparin, low dose unfractionated heparin, or fondaparinux in hospitalized medically ill patients is associated with ~50% reduction in venous thromboembolism (VTE) risk. However, these patients remain at high risk for VTE post-discharge. The direct oral anticoagulants (DOACs) apixaban, rivaroxaban and betrixaban have been evaluated for extended-duration (30-42 days) thromboprophylaxis in this population. We review the efficacy and safety results from the 3 pivotal trials of extended-duration DOAC thromboprophylaxis in medically ill patients. We performed a meta-analysis of these pivotal trials focusing on 6 VTE (efficacy) and three bleeding outcomes (safety). These results were integrated into a quantitative risk/benefit assessment. The trials evaluating extended-duration DOAC thromboprophylaxis in medically ill patients failed to establish clear efficacy and/or safety signals for each agent. Our meta-analysis shows that, as a class, DOACs have selective and partial extended-duration prophylactic activity in preventing VTE events. However, this is associated with a marked increase in the risk of various bleeding events. The risk/benefit analyses fail to show a consistent net clinical benefit of extended-duration DOAC prophylaxis in medically ill patients. At this time, the evidence of safe and effective extended-duration thromboprophylaxis with DOACs in this population is inconclusive.

Evaluation of criteria for developing traffic safety materials for Latinos.

PubMed

Streit-Kaplan, Erica L; Miara, Christine; Formica, Scott W; Gallagher, Susan Scavo

2011-03-01

This quantitative study assessed the validity of guidelines that identified four key characteristics of culturally appropriate Spanish-language traffic safety materials: language, translation, formative evaluation, and credible source material. From a sample of 190, the authors randomly selected 12 Spanish-language educational materials for analysis by 15 experts. Hypotheses included that the experts would rate materials with more of the key characteristics as more effective (likely to affect behavioral change) and rate materials originally developed in Spanish and those that utilized formative evaluation (e.g., pilot tests, focus groups) as more culturally appropriate. Although results revealed a weak association between the number of key characteristics in a material and the rating of its effectiveness, reviewers rated materials originally created in Spanish and those utilizing formative evaluation as significantly more culturally appropriate. The findings and methodology demonstrated important implications for developers and evaluators of any health-related materials for Spanish speakers and other population groups.

Soft error evaluation and vulnerability analysis in Xilinx Zynq-7010 system-on chip

NASA Astrophysics Data System (ADS)

Du, Xuecheng; He, Chaohui; Liu, Shuhuan; Zhang, Yao; Li, Yonghong; Xiong, Ceng; Tan, Pengkang

2016-09-01

Radiation-induced soft errors are an increasingly important threat to the reliability of modern electronic systems. In order to evaluate system-on chip's reliability and soft error, the fault tree analysis method was used in this work. The system fault tree was constructed based on Xilinx Zynq-7010 All Programmable SoC. Moreover, the soft error rates of different components in Zynq-7010 SoC were tested by americium-241 alpha radiation source. Furthermore, some parameters that used to evaluate the system's reliability and safety were calculated using Isograph Reliability Workbench 11.0, such as failure rate, unavailability and mean time to failure (MTTF). According to fault tree analysis for system-on chip, the critical blocks and system reliability were evaluated through the qualitative and quantitative analysis.

Quantitative analysis of pedestrian safety at uncontrolled multi-lane mid-block crosswalks in China.

PubMed

Zhang, Cunbao; Zhou, Bin; Chen, Guojun; Chen, Feng

2017-11-01

A lot of pedestrian-vehicle crashes at mid-block crosswalks severely threaten pedestrian's safety around the world. The situations are even worse in China due to low yielding rate of vehicles at crosswalks. In order to quantitatively analyze pedestrian's safety at multi-lane mid-block crosswalks, the number of pedestrian-vehicle conflicts was utilized to evaluate pedestrian's accident risk. Five mid-block crosswalks (Wuhan, China) were videoed to collect data of traffic situation and pedestrian-vehicle conflicts, and the quantity and spatial distribution of pedestrian-vehicle conflicts at multi-lane mid-block crosswalk were analyzed according to lane-based post-encroachment time(LPET). Statistical results indicate that conflicts are mainly concentrated in lane3 and lane6. Percentage of conflict of each lane numbered from 1 to 6 respectively are 4.1%, 13.1%, 19.8%, 8.4%, 19.0%, 28.1%. Conflict rate under different crossing strategies are also counted. Moreover, an order probit (OP) model of pedestrian-vehicle conflict analysis (PVCA) was built to find out the contributions corresponding to those factors (such as traffic volume, vehicle speed, pedestrian crossing behavior, pedestrian refuge, etc.) to pedestrian-vehicle conflicts. The results show that: pedestrian refuge have positive effects on pedestrian safety; on the other hand, high vehicle speed, high traffic volume, rolling gap crossing pattern, and larger pedestrian platoon have negative effects on pedestrian safety. Based on our field observation and PVCA model, the number of conflicts will rise by 2% while the traffic volume increases 200 pcu/h; similarly, if the vehicle speed increases 5km/h, the number of conflicts will rise by 12% accordingly. The research results could be used to evaluate pedestrian safety at multi-lane mid-block crosswalks, and useful to improve pedestrian safety by means of pedestrian safety education, pedestrian refuge setting, vehicle speed limiting, and so on. Copyright © 2017 Elsevier Ltd. All rights reserved.

Taking up national safety alerts to improve patient safety in hospitals: The perspective of healthcare quality and risk managers.

PubMed

Pfeiffer, Yvonne; Schwappach, David

2016-01-01

National safety alert systems publish relevant information to improve patient safety in hospitals. However, the information has to be transformed into local action to have an effect on patient safety. We studied three research questions: How do Swiss healthcare quality and risk managers (qm/rm(1)) see their own role in learning from safety alerts issued by the Swiss national voluntary reporting and analysis system? What are their attitudes towards and evaluations of the alerts, and which types of improvement actions were fostered by the safety alerts? A survey was developed and applied to Swiss healthcare risk and quality managers, with a response rate of 39 % (n=116). Descriptive statistics are presented. The qm/rm disseminate and communicate with a broad variety of professional groups about the alerts. While most respondents felt that they should know the alerts and their contents, only a part of them felt responsible for driving organizational change based on the recommendations. However, most respondents used safety alerts to back up their own patient safety goals. The alerts were evaluated positively on various dimensions such as usefulness and were considered as standards of good practice by the majority of the respondents. A range of organizational responses was applied, with disseminating information being the most common. An active role is related to using safety alerts for backing up own patient safety goals. To support an active role of qm/rm in their hospital's learning from safety alerts, appropriate organizational structures should be developed. Furthermore, they could be given special information or training to act as an information hub on the issues discussed in the alerts. Copyright © 2016. Published by Elsevier GmbH.

NASA Accident Precursor Analysis Handbook, Version 1.0

NASA Technical Reports Server (NTRS)

Groen, Frank; Everett, Chris; Hall, Anthony; Insley, Scott

2011-01-01

Catastrophic accidents are usually preceded by precursory events that, although observable, are not recognized as harbingers of a tragedy until after the fact. In the nuclear industry, the Three Mile Island accident was preceded by at least two events portending the potential for severe consequences from an underappreciated causal mechanism. Anomalies whose failure mechanisms were integral to the losses of Space Transportation Systems (STS) Challenger and Columbia had been occurring within the STS fleet prior to those accidents. Both the Rogers Commission Report and the Columbia Accident Investigation Board report found that processes in place at the time did not respond to the prior anomalies in a way that shed light on their true risk implications. This includes the concern that, in the words of the NASA Aerospace Safety Advisory Panel (ASAP), "no process addresses the need to update a hazard analysis when anomalies occur" At a broader level, the ASAP noted in 2007 that NASA "could better gauge the likelihood of losses by developing leading indicators, rather than continue to depend on lagging indicators". These observations suggest a need to revalidate prior assumptions and conclusions of existing safety (and reliability) analyses, as well as to consider the potential for previously unrecognized accident scenarios, when unexpected or otherwise undesired behaviors of the system are observed. This need is also discussed in NASA's system safety handbook, which advocates a view of safety assurance as driving a program to take steps that are necessary to establish and maintain a valid and credible argument for the safety of its missions. It is the premise of this handbook that making cases for safety more experience-based allows NASA to be better informed about the safety performance of its systems, and will ultimately help it to manage safety in a more effective manner. The APA process described in this handbook provides a systematic means of analyzing candidate accident precursors by evaluating anomaly occurrences for their system safety implications and, through both analytical and deliberative methods used to project to other circumstances, identifying those that portend more serious consequences to come if effective corrective action is not taken. APA builds upon existing safety analysis processes currently in practice within NASA, leveraging their results to provide an improved understanding of overall system risk. As such, APA represents an important dimension of safety evaluation; as operational experience is acquired, precursor information is generated such that it can be fed back into system safety analyses to risk-inform safety improvements. Importantly, APA utilizes anomaly data to predict risk whereas standard reliability and PRA approaches utilize failure data which often is limited and rare.

When paradigms collide at the road rail interface: evaluation of a sociotechnical systems theory design toolkit for cognitive work analysis.

PubMed

Read, Gemma J M; Salmon, Paul M; Lenné, Michael G

2016-09-01

The Cognitive Work Analysis Design Toolkit (CWA-DT) is a recently developed approach that provides guidance and tools to assist in applying the outputs of CWA to design processes to incorporate the values and principles of sociotechnical systems theory. In this paper, the CWA-DT is evaluated based on an application to improve safety at rail level crossings. The evaluation considered the extent to which the CWA-DT met pre-defined methodological criteria and aligned with sociotechnical values and principles. Both process and outcome measures were taken based on the ratings of workshop participants and human factors experts. Overall, workshop participants were positive about the process and indicated that it met the methodological criteria and sociotechnical values. However, expert ratings suggested that the CWA-DT achieved only limited success in producing RLX designs that fully aligned with the sociotechnical approach. Discussion about the appropriateness of the sociotechnical approach in a public safety context is provided. Practitioner Summary: Human factors and ergonomics practitioners need evidence of the effectiveness of methods. A design toolkit for cognitive work analysis, incorporating values and principles from sociotechnical systems theory, was applied to create innovative designs for rail level crossings. Evaluation results based on the application are provided and discussed.

Review and Enhancement for Crash Analysis and Prediction: Phase 1 Evaluation of the Crash Studies and Analysis Standard Operating Procedures in Maryland

DOT National Transportation Integrated Search

2010-03-01

Traffic safety has become one of the most critical issues facing transportation agencies across the nation. In 2006, about 43,000 people were killed, and another 290,000 were seriously injured in crashes on public roadways in the United States. Accor...

Bayesian Inference for NASA Probabilistic Risk and Reliability Analysis

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Kelly, Dana; Smith, Curtis; Vedros, Kurt; Galyean, William

2009-01-01

This document, Bayesian Inference for NASA Probabilistic Risk and Reliability Analysis, is intended to provide guidelines for the collection and evaluation of risk and reliability-related data. It is aimed at scientists and engineers familiar with risk and reliability methods and provides a hands-on approach to the investigation and application of a variety of risk and reliability data assessment methods, tools, and techniques. This document provides both: A broad perspective on data analysis collection and evaluation issues. A narrow focus on the methods to implement a comprehensive information repository. The topics addressed herein cover the fundamentals of how data and information are to be used in risk and reliability analysis models and their potential role in decision making. Understanding these topics is essential to attaining a risk informed decision making environment that is being sought by NASA requirements and procedures such as 8000.4 (Agency Risk Management Procedural Requirements), NPR 8705.05 (Probabilistic Risk Assessment Procedures for NASA Programs and Projects), and the System Safety requirements of NPR 8715.3 (NASA General Safety Program Requirements).

The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial.

PubMed

Zhang, Ying; Sun, Jin; Zhang, Yun-Jiao; Chai, Qian-Yun; Zhang, Kang; Ma, Hong-Li; Wu, Xiao-Ke; Liu, Jian-Ping

2016-10-21

Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting. We specified detailed methods for data management and statistical analyses. Statistics in corresponding tables, listings, and graphs were outlined. The SAP provided more detailed information than trial protocol on data management and statistical analysis methods. Any post hoc analyses could be identified via referring to this SAP, and the possible selection bias and performance bias will be reduced in the trial. This study is registered at ClinicalTrials.gov, NCT01138930 , registered on 7 June 2010.

Probiotic and synbiotic safety in infants under two years of age.

PubMed

van den Nieuwboer, M; Claassen, E; Morelli, L; Guarner, F; Brummer, R J

2014-03-01

In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.

Applications of hyperspectral imaging in chicken meat safety and quality detection and evaluation: a review.

PubMed

Xiong, Zhenjie; Xie, Anguo; Sun, Da-Wen; Zeng, Xin-An; Liu, Dan

2015-01-01

Currently, the issue of food safety and quality is a great public concern. In order to satisfy the demands of consumers and obtain superior food qualities, non-destructive and fast methods are required for quality evaluation. As one of these methods, hyperspectral imaging (HSI) technique has emerged as a smart and promising analytical tool for quality evaluation purposes and has attracted much interest in non-destructive analysis of different food products. With the main advantage of combining both spectroscopy technique and imaging technique, HSI technique shows a convinced attitude to detect and evaluate chicken meat quality objectively. Moreover, developing a quality evaluation system based on HSI technology would bring economic benefits to the chicken meat industry. Therefore, in recent years, many studies have been conducted on using HSI technology for the safety and quality detection and evaluation of chicken meat. The aim of this review is thus to give a detailed overview about HSI and focus on the recently developed methods exerted in HSI technology developed for microbiological spoilage detection and quality classification of chicken meat. Moreover, the usefulness of HSI technique for detecting fecal contamination and bone fragments of chicken carcasses are presented. Finally, some viewpoints on its future research and applicability in the modern poultry industry are proposed.

[Drug safety warnings in psychiatry: adverse drug reactions' signaling from 2002 to 2014].

PubMed

Prisco, Vincenzo; Iannaccone, Teresa; Tusciano, Adriano; Boccardi, Mariangela; Perris, Francesco; Capuano, Annalisa; Catapano, Francesco; Fabrazzo, Michele

2016-01-01

Monitoring drug-related side effects in psychiatric patients is highly recommended. In fact, frequent exposure to long-term polipharmacotherapy, poor compliance to pharmachological treatment and comorbidity with organic illnesses requiring the prescription of other drugs are causes of pharmacokinetic/pharmacodynamic interactions. These vulnerability factors result in a certain increase in adverse drug reactions (ADRs). This study performes an analysis of Italian Medicine Agency data, in the section "signal analysis", to attempt an assessment of the safety warnings among the different psychotropic drug classes, belonging to the ATC class: N03 (antiepileptics), N05 (antipsychotics), N06 (psycho-analectic drugs). Then we analysed, in a descriptive way, the different association between the drug and the related ADR, evaluating the different safety profiles, in relation to experimental studies, supporting the importance of the signal. In the last years, among the new 25 ADRs, 10 were related to antidepressant drugs (8 SSRI, 1 mirtazapine, 1 agomelatine). In relation to antipsychotic drugs, 6 new correlations were found between drug and ADR onset, mainly among atypical antispychotics. Other correlations (6 above all) were found among antiepileptic drugs. Among benzodiazepines, a signal linked to rabdomylysis onset was found. It is also recommended an evaluation of safety profile in relation to zolpidem prescription. The results of our systematic review are a motivational input, considering the continuous increase of safety warnings, to attentively monitor drug's prescription. Spontaneous ADRs' signaling is a classical system to provide the required attention in relation to a potential risk. The clinician in charge must report this because he is the key figure in the drugs' safety process. In psychiatry, in which a long-term pharmachological therapy is frequent, clinicians are requested to find and signal ADRs to the competent authority.

Offsite radiological consequence analysis for the bounding flammable gas accident

DOE Office of Scientific and Technical Information (OSTI.GOV)

CARRO, C.A.

2003-03-19

The purpose of this analysis is to calculate the offsite radiological consequence of the bounding flammable gas accident. DOE-STD-3009-94, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'', requires the formal quantification of a limited subset of accidents representing a complete set of bounding conditions. The results of these analyses are then evaluated to determine if they challenge the DOE-STD-3009-94, Appendix A, ''Evaluation Guideline,'' of 25 rem total effective dose equivalent in order to identify and evaluate safety class structures, systems, and components. The bounding flammable gas accident is a detonation in a single-shell tank (SST).more » A detonation versus a deflagration was selected for analysis because the faster flame speed of a detonation can potentially result in a larger release of respirable material. As will be shown, the consequences of a detonation in either an SST or a double-shell tank (DST) are approximately equal. A detonation in an SST was selected as the bounding condition because the estimated respirable release masses are the same and because the doses per unit quantity of waste inhaled are generally greater for SSTs than for DSTs. Appendix A contains a DST analysis for comparison purposes.« less

Scale/TSUNAMI Sensitivity Data for ICSBEP Evaluations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rearden, Bradley T; Reed, Davis Allan; Lefebvre, Robert A

2011-01-01

The Tools for Sensitivity and Uncertainty Analysis Methodology Implementation (TSUNAMI) software developed at Oak Ridge National Laboratory (ORNL) as part of the Scale code system provide unique methods for code validation, gap analysis, and experiment design. For TSUNAMI analysis, sensitivity data are generated for each application and each existing or proposed experiment used in the assessment. The validation of diverse sets of applications requires potentially thousands of data files to be maintained and organized by the user, and a growing number of these files are available through the International Handbook of Evaluated Criticality Safety Benchmark Experiments (IHECSBE) distributed through themore » International Criticality Safety Benchmark Evaluation Program (ICSBEP). To facilitate the use of the IHECSBE benchmarks in rigorous TSUNAMI validation and gap analysis techniques, ORNL generated SCALE/TSUNAMI sensitivity data files (SDFs) for several hundred benchmarks for distribution with the IHECSBE. For the 2010 edition of IHECSBE, the sensitivity data were generated using 238-group cross-section data based on ENDF/B-VII.0 for 494 benchmark experiments. Additionally, ORNL has developed a quality assurance procedure to guide the generation of Scale inputs and sensitivity data, as well as a graphical user interface to facilitate the use of sensitivity data in identifying experiments and applying them in validation studies.« less

Methods and strategies for future reactor safety goals

NASA Astrophysics Data System (ADS)

Arndt, Steven Andrew

There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk-informed analyses and discussions. This dissertation examines potential approaches to updating the safety goals that include the establishment of new quantitative safety goal associated with the comparative risk of generating electricity by viable competing technologies and modifications of the goals to account for multi-plant reactor sites, and issues associated with the use of safety goals in both initial licensing and operational decision making. This research develops a new quantitative health objective that uses a comparable benefit risk metric based on the life-cycle risk of the construction, operation and decommissioning of a comparable non-nuclear electric generation facility, as well as the risks associated with mining and transportation. This dissertation also evaluates the effects of using various methods for aggregating site risk as a safety metric, as opposed to using single plant safety goals. Additionally, a number of important assumptions inherent in the current safety goals, including the effect of other potential negative societal effects such as the generation of greenhouse gases (e.g., carbon dioxide) have on the risk of electric power production and their effects on the setting of safety goals, is explored. Finally, the role risk perception should play in establishing safety goals has been explored. To complete this evaluation, a new method to analytically compare alternative technologies of generating electricity was developed, including development of a new way to evaluate risk perception, and a new method was developed for evaluating the risk at multiple units on a single site. To test these modifications to the safety goals a number of possible reactor designs and configurations were evaluated using these new proposed safety goals to determine the goals' usefulness and utility. The results of the analysis showed that the modifications provide measures that more closely evaluate the potential risk to the public from the operation of nuclear power plants than the current safety goals, while still providing a straight-forward process for assessment of reactor design and operation.

78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... methodological issues that arise in the use of meta-analyses to evaluate safety risks, followed by a discussion... design, conduct and use of meta-analysis. Although many external stakeholders conduct meta-analyses, FDA... meeting. FDA expects that this meeting will build upon prior stakeholder feedback on the design, conduct...

75 FR 24958 - Decision To Evaluate a Petition To Designate a Class of Employees From the Hanford Site, Richland...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-06

... warranted by the evaluation, is as follows: Facility: Hanford site. Location: Richland, Washington. Job Titles and/or Job Duties: All personnel who were internally monitored (urine or fecal), who worked at the... Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway...

75 FR 55792 - Decision To Evaluate a Petition To Designate a Class of Employees From the Wah Chang Facility...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-14

... warranted by the evaluation, is as follows: Facility: Wah Chang. Location: Albany, Oregon. Job Titles and/or Job Duties: All employees who worked in any buildings. Period of Employment: Operational period from... of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH...

The Development and Initial Evaluation of the Human Readiness Level Framework

DTIC Science & Technology

2010-06-01

View ICD Initial Capabilities Document ICW Interactive Course Ware ILE Interactive Learning Environment ILT Instructor Led Training IOC...Programmatic Environmental Safety and Health Evaluation PHA Preliminary Hazard Analysis PHL Preliminary Hazard List xiv PM Program Manager PQS...Occupational Health SOW Statement of Work SRD System Requirements Document SPS System Performance Specification SRR System Requirements Review SVR

DOE Office of Scientific and Technical Information (OSTI.GOV)

MCCOY, J.C.

This Safety Analysis Report for Packaging (SARP) provides a technical evaluation of the Sample Pig Transport System as compared to the requirements of the U.S. Department of Energy, Richland Operations Office (RL) Order 5480.1, Change 1, Chapter III. The evaluation concludes that the package is acceptable for the onsite transport of Type B, fissile excepted radioactive materials when used in accordance with this document.

[Concept analysis of a participatory approach to occupational safety and health].

PubMed

Yoshikawa, Etsuko

2013-01-01

The purpose of this study was to analyze a participatory approach to occupational safety and health, and to examine the possibility of applying the concept to the practice and research of occupational safety and health. According to Rodger's method, descriptive data concerning antecedents, attributes and consequences were qualitatively analyzed. A total of 39 articles were selected for analysis. Attributes with a participatory approach were: "active involvement of both workers and employers", "focusing on action-oriented low-cost and multiple area improvements based on good practices", "the process of emphasis on consensus building", and "utilization of a local network". Antecedents of the participatory approach were classified as: "existing risks at the workplace", "difficulty of occupational safety and health activities", "characteristics of the workplace and workers", and "needs for the workplace". The derived consequences were: "promoting occupational safety and health activities", "emphasis of self-management", "creation of safety and healthy workplace", and "contributing to promotion of quality of life and productivity". A participatory approach in occupational safety and health is defined as, the process of emphasis on consensus building to promote occupational safety and health activities with emphasis on self-management, which focuses on action-oriented low-cost and multiple area improvements based on good practices with active involvement of both workers and employers through utilization of local networks. We recommend that the role of the occupational health professional be clarified and an evaluation framework be established for the participatory approach to promote occupational safety and health activities by involving both workers and employers.

Food additives: an ethical evaluation.

PubMed

Mepham, Ben

2011-01-01

Food additives are an integral part of the modern food system, but opinion polls showing most Europeans have worries about them imply an urgent need for ethical analysis of their use. The existing literature on food ethics, safety assessment and animal testing. Food additives provide certain advantages in terms of many people's lifestyles. There are disagreements about the appropriate application of the precautionary principle and of the value and ethical validity of animal tests in assessing human safety. Most consumers have a poor understanding of the relative benefits and risks of additives, but concerns over food safety and animal testing remain high. Examining the impacts of food additives on consumer sovereignty, consumer health and on animals used in safety testing should allow a more informed debate about their appropriate uses.

Study on the evaluation index of active power reserve

NASA Astrophysics Data System (ADS)

Guo, Xiaorui; Liu, Jiantao; Wang, Ke; Min, Lu

2018-01-01

Based on the role of active reserve at different time scales, divides the evaluation dimension of active reserve. Analysis the calculation principle of traditional reliability index such as probability of system safety, lack of power shortage and electricity shortage expectancy, and studies the applicability of these indicators to evaluate the reserve capacity on different dimensions. Resolves the evaluation index of active reserve capacity from the dimensions of time dimension, spatial dimension, system state, risk degree and economy, then construct evaluation index of active reserve capacity.

Diagnosis of poor safety culture as a major shortcoming in OHSAS 18001-certified companies.

PubMed

Ghahramani, Abolfazl

2017-04-07

The evaluation of safety performance in occupational health and safety assessment series (OHSAS) 18001-certified companies provides useful information about the quality of the management system. A certified organization should employ an adequate level of safety management and a positive safety culture to achieve a satisfactory safety performance. The present study conducted in six manufacturing companies: three OHSAS 18001-certified, and three non-certified to assess occupational health and safety (OHS) as well as OHSAS 18001 practices. The certified companies had a better OHS practices compared with the non-certified companies. The certified companies slightly differed in OHS and OHSAS 18001 practices and one of the certified companies had the highest activity rates for both practices. The results indicated that the implemented management systems have not developed and been maintained appropriately in the certified companies. The in-depth analysis of the collected evidence revealed shortcomings in safety culture improvement in the certified companies. This study highlights the importance of safety culture to continuously improve the quality of OHSAS 18001 and to properly perform OHS/OHSAS 18001 practices in the certified companies.

Diagnosis of poor safety culture as a major shortcoming in OHSAS 18001-certified companies

PubMed Central

GHAHRAMANI, Abolfazl

2016-01-01

The evaluation of safety performance in occupational health and safety assessment series (OHSAS) 18001-certified companies provides useful information about the quality of the management system. A certified organization should employ an adequate level of safety management and a positive safety culture to achieve a satisfactory safety performance. The present study conducted in six manufacturing companies: three OHSAS 18001-certified, and three non-certified to assess occupational health and safety (OHS) as well as OHSAS 18001 practices. The certified companies had a better OHS practices compared with the non-certified companies. The certified companies slightly differed in OHS and OHSAS 18001 practices and one of the certified companies had the highest activity rates for both practices. The results indicated that the implemented management systems have not developed and been maintained appropriately in the certified companies. The in-depth analysis of the collected evidence revealed shortcomings in safety culture improvement in the certified companies. This study highlights the importance of safety culture to continuously improve the quality of OHSAS 18001 and to properly perform OHS/OHSAS 18001 practices in the certified companies. PMID:28025422

Newspaper content analysis in evaluation of a community-based participatory project to increase physical activity.

PubMed

Granner, Michelle L; Sharpe, Patricia A; Burroughs, Ericka L; Fields, Regina; Hallenbeck, Joyce

2010-08-01

This study conducted a newspaper content analysis as part of an evaluation of a community-based participatory research project focused on increasing physical activity through policy and environmental changes, which included activities related to media advocacy and media-based community education. Daily papers (May 2003 to December 2005) from both the intervention and comparison counties were reviewed for topics related to physical activity and an active living environment (e.g. safety, policy, urban design, transportation and recreational resources). A total of 2681 articles from 1764 newspapers were analyzed. The intervention county had a greater proportion of articles on the selected topics. Specifically, the intervention county had a greater proportion of articles in topics related to safety, policy and community initiatives, as well as in sidewalks and recreational facilities; both priority areas for the intervention. Prominence of the articles was assessed using a composite index score. Generally, prominence of the topics analyzed was low. Articles in the sidewalks and recreational facilities topic category in the intervention county had higher prominence scores on average than the comparison county. The study demonstrates that media content analysis can be a valuable component in evaluating community-based interventions.

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

PubMed

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

Relating crash frequency and severity: evaluating the effectiveness of shoulder rumble strips on reducing fatal and major injury crashes.

PubMed

Wu, Kun-Feng; Donnell, Eric T; Aguero-Valverde, Jonathan

2014-06-01

To approach the goal of "Toward Zero Deaths," there is a need to develop an analysis paradigm to better understand the effects of a countermeasure on reducing the number of severe crashes. One of the goals in traffic safety research is to search for an effective treatment to reduce fatal and major injury crashes, referred to as severe crashes. To achieve this goal, the selection of promising countermeasures is of utmost importance, and relies on the effectiveness of candidate countermeasures in reducing severe crashes. Although it is important to precisely evaluate the effectiveness of candidate countermeasures in reducing the number of severe crashes at a site, the current state-of-the-practice often leads to biased estimates. While there have been a few advanced statistical models developed to mitigate the problem in practice, these models are computationally difficult to estimate because severe crashes are dispersed spatially and temporally, and cannot be integrated into the Highway Safety Manual framework, which develops a series of safety performance functions and crash modification factors to predict the number of crashes. Crash severity outcomes are generally integrated into the Highway Safety Manual using deterministic distributions rather than statistical models. Accounting for the variability in crash severity as a function geometric design, traffic flow, and other roadway and roadside features is afforded by estimating statistical models. Therefore, there is a need to develop a new analysis paradigm to resolve the limitations in the current Highway Safety Manual methods. We propose an approach which decomposes the severe crash frequency into a function of the change in the total number of crashes and the probability of a crash becoming a severe crash before and after a countermeasure is implemented. We tested this approach by evaluating the effectiveness of shoulder rumble strips on reducing the number of severe crashes. A total of 310 segments that have had shoulder rumble strips installed during 2002-2009 are included in the analysis. It was found that shoulder rumble strips reduce the total number of crashes, but have no statistically significant effect on reducing the probability of a severe crash outcome. Copyright © 2014 Elsevier Ltd. All rights reserved.

Note on evaluating safety performance of road infrastructure to motivate safety competition.

PubMed

Han, Sangjin

2016-01-01

Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

21 CFR 315.6 - Evaluation of safety.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...)(1) To establish the safety of a diagnostic radiopharmaceutical, FDA may require, among other...

77 FR 34950 - Decision To Evaluate a Petition To Designate a Class of Employees From the Clarksville Facility...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

...: Clarksville Facility. Location: Clarksville, Tennessee. Job Titles and/or Job Duties: Workers potentially..., Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676...

Road weather connected vehicle applications : benefit-cost analysis interim report.

DOT National Transportation Integrated Search

2013-01-01

RWMP is currently engaged in a project to evaluate the potential benefits of road weather connected vehicle applications. Of particular interest are the potential improvements in safety, reductions in travel time, improved travel reliability, reducti...

Traffic conflict techniques for safety and operations : observers manual

DOT National Transportation Integrated Search

2012-08-01

This report presents the test plan for conducting the Institutional and Organizational Analysis for the United States Department of Transportation (U.S. DOT) evaluation of the San Diego Integrated Corridor Management (ICM) Initiative Demonstration. T...

Safety I-II, resilience and antifragility engineering: a debate explained through an accident occurring on a mobile elevating work platform.

PubMed

Martinetti, Alberto; Chatzimichailidou, Maria Mikela; Maida, Luisa; van Dongen, Leo

2018-04-24

Occupational health and safety (OHS) represents an important field of exploration for the research community: in spite of the growth of technological innovations, the increasing complexity of systems involves critical issues in terms of degradation of the safety levels. In such a situation, new safety management approaches are now mandatory in order to face the safety implications of the current technological evolutions. Along these lines, performing risk-based analysis alone seems not to be enough anymore. The evaluation of robustness, antifragility and resilience of a socio-technical system is now indispensable in order to face unforeseen events. This article will briefly introduce the topics of Safety I and Safety II, resilience engineering and antifragility engineering, explaining correlations, overlapping aspects and synergies. Secondly, the article will discuss the applications of those paradigms to a real accident, highlighting how they can challenge, stimulate and inspire research for improving OHS conditions.

Middle East food safety perspectives.

PubMed

Idriss, Atef W; El-Habbab, Mohammad S

2014-08-01

Food safety and quality assurance are increasingly a major issue with the globalisation of agricultural trade, on the one hand, and intensification of agriculture, on the other. Consumer protection has become a priority in policy-making amongst the large economies of the Middle East and North Africa (MENA) countries following a number of food safety incidents. To enhance food safety, it is necessary to establish markets underpinned by knowledge and resources, including analysis of international rejections of food products from MENA countries, international laboratory accreditation, improved reporting systems and traceability, continued development and validation of analytical methods, and more work on correlating sensory evaluation with analytical results. MENA countries should develop a national strategy for food safety based on a holistic approach that extends from farm-to-fork and involves all the relevant stakeholders. Accordingly, food safety should be a regional programme, raising awareness among policy- and decision-makers of the importance of food safety and quality for consumer protection, food trade and economic development. © 2014 Society of Chemical Industry.

Efficacy and safety of bisphosphonates in management of low bone density in inflammatory bowel disease: A meta-analysis.

PubMed

Yao, Liwei; Wang, Haiqing; Dong, Wenwei; Liu, Zhenxin; Mao, Haijiao

2017-01-01

This study aims to determine whether bisphosphonates are safe, as well as effective against bone mineral loss in inflammatory bowel disease (IBD). A computerized search of electronic databases from 1966 to 2016 was performed. Randomized controlled trials (RCTs) were included in this review to evaluate the role of bisphosphonates in the management of osteoporosis in IBD patients. A revised 7-point Jadad scale was used to evaluate the quality of each study. Overall, 13 RCTs and 923 patients met the inclusion criteria of this meta-analysis. The result showed that bisphosphonates decreased bone mass density (BMD) loss at the lumbar spine (P = 0.0002), reduced the risk of new fractures (P = 0.01), and retained the similar adverse events (P = 0.86). Bisphosphonates may provide protection and safety against bone mineral loss in IBD patients.

[Performance and safety at work].

PubMed

Bentivegna, M

2010-01-01

The evaluative approach of occupational therapy, centred on the person, on an analysis of performance and an assessment of the work environment, can provide important information for planning interventions to increase safety at work. The reliability of work performance is influenced by many factors, some of which are not directly dependent on humans, such as those related to the environment, to materials, to spaces, to places and to the organization of work; others, however, are closely related to human behaviours. For this reason, for the purpose of ensuring prevention of all harmful events, the process of risk evaluation must also include an analysis of the role of human behaviour and functional capacity. In our daily clinical practice, we Occupational Therapists use work to promote the wellbeing and health of people by involving them in activities, with the knowledge that every occupation is perceived by an individual as something particularly personal and significant.

Comprehensive assessment of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis.

PubMed

Valeyre, Dominique; Albera, Carlo; Bradford, Williamson Z; Costabel, Ulrich; King, Talmadge E; Leff, Jonathan A; Noble, Paul W; Sahn, Steven A; du Bois, Roland M

2014-07-01

Pirfenidone is an oral antifibrotic agent that is approved in several countries for the treatment of idiopathic pulmonary fibrosis (IPF). We performed a comprehensive analysis of safety across four clinical trials evaluating pirfenidone in patients with IPF. All patients receiving pirfenidone 2403 mg/day in the Phase 3 CAPACITY studies (Studies 004 and 006) and all patients receiving at least one dose of pirfenidone in one of two ongoing open-label studies in patients with IPF (Studies 002 and 012) were selected for inclusion. Safety outcomes were evaluated from baseline until 28 days after the last dose of study drug. A total of 789 patients were included in the analysis. The median duration of exposure to pirfenidone was 2.6 years (range, 1 week-7.7 years), and the cumulative total exposure was 2059 person exposure years (PEY). Gastrointestinal and skin-related events were the most commonly reported adverse events; these were almost always mild to moderate in severity, and rarely led to treatment discontinuation. Elevations (>3× upper limit of normal) in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) occurred in 21/789 (2.7%) patients; the adjusted incidence of AST/ALT elevations was 1.7 per 100 PEY. This comprehensive analysis of safety in a large cohort of IPF patients receiving pirfenidone for a total of 2059 PEY demonstrates that long-term treatment with pirfenidone is safe and generally well tolerated. © 2014 The Authors. Respirology published by Wiley Publishing Asia Pty Ltd on behalf of Asian Pacific Society of Respirology.

The determination of elements in herbal teas and medicinal plant formulations and their tisanes.

PubMed

Pohl, Pawel; Dzimitrowicz, Anna; Jedryczko, Dominika; Szymczycha-Madeja, Anna; Welna, Maja; Jamroz, Piotr

2016-10-25

Elemental analysis of herbal teas and their tisanes is aimed at assessing their quality and safety in reference to specific food safety regulations and evaluating their nutritional value. This survey is dedicated to atomic spectroscopy and mass spectrometry element detection methods and sample preparation procedures used in elemental analysis of herbal teas and medicinal plant formulations. Referring to original works from the last 15 years, particular attention has been paid to tisane preparation, sample matrix decomposition, calibration and quality assurance of results in elemental analysis of herbal teas by different atomic and mass spectrometry methods. In addition, possible sources of elements in herbal teas and medicinal plant formulations have been discussed. Copyright © 2016 Elsevier B.V. All rights reserved.

Neutronic and thermal-hydraulic analysis of fission molybdenum-99 production at Tehran Research Reactor using LEU plate targets.

PubMed

Abedi, Ebrahim; Ebrahimkhani, Marzieh; Davari, Amin; Mirvakili, Seyed Mohammad; Tabasi, Mohsen; Maragheh, Mohammad Ghannadi

2016-12-01

Efficient and safe production of molybdenum-99 ( 99 Mo) radiopharmaceutical at Tehran Research Reactor (TRR) via fission of LEU targets is studied. Neutronic calculations are performed to evaluate produced 99 Mo activity, core neutronic safety parameters and also the power deposition values in target plates during a 7 days irradiation interval. Thermal-hydraulic analysis has been also carried out to obtain thermal behavior of these plates. Using Thermal-hydraulic analysis, it can be concluded that the safety parameters are satisfied in the current study. Consequently, the present neutronic and thermal-hydraulic calculations show efficient 99 Mo production is accessible at significant activity values in TRR current core configuration. Copyright © 2016 Elsevier Ltd. All rights reserved.

A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris.

PubMed

Jones, Terry M; Jarratt, Michael T; Mendez-Moguel, Ines; Paz, Nelly; Grekin, Steven K; Cognata Smith, Christina; Kaur, Mandeep

2014-01-01

Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis. This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris. 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments. Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle. The study was conducted under controlled conditions in a relatively small population. Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.

Developing Methodologies for Evaluating the Earthquake Safety of Existing Buildings.

ERIC Educational Resources Information Center

Bresler, B.; And Others

This report contains four papers written during an investigation of methods for evaluating the safety of existing school buildings under Research Applied to National Needs (RANN) grants. In "Evaluation of Earthquake Safety of Existing Buildings," by B. Bresler, preliminary ideas on the evaluation of the earthquake safety of existing…

Pharmacology-based toxicity assessment: towards quantitative risk prediction in humans.

PubMed

Sahota, Tarjinder; Danhof, Meindert; Della Pasqua, Oscar

2016-05-01

Despite ongoing efforts to better understand the mechanisms underlying safety and toxicity, ~30% of the attrition in drug discovery and development is still due to safety concerns. Changes in current practice regarding the assessment of safety and toxicity are required to reduce late stage attrition and enable effective development of novel medicines. This review focuses on the implications of empirical evidence generation for the evaluation of safety and toxicity during drug development. A shift in paradigm is needed to (i) ensure that pharmacological concepts are incorporated into the evaluation of safety and toxicity; (ii) facilitate the integration of historical evidence and thereby the translation of findings across species as well as between in vitro and in vivo experiments and (iii) promote the use of experimental protocols tailored to address specific safety and toxicity questions. Based on historical examples, we highlight the challenges for the early characterisation of the safety profile of a new molecule and discuss how model-based methodologies can be applied for the design and analysis of experimental protocols. Issues relative to the scientific rationale are categorised and presented as a hierarchical tree describing the decision-making process. Focus is given to four different areas, namely, optimisation, translation, analytical construct and decision criteria. From a methodological perspective, the relevance of quantitative methods for estimation and extrapolation of risk from toxicology and safety pharmacology experimental protocols, such as points of departure and potency, is discussed in light of advancements in population and Bayesian modelling techniques (e.g. non-linear mixed effects modelling). Their use in the evaluation of pharmacokinetics (PK) and pharmacokinetic-pharmacodynamic relationships (PKPD) has enabled great insight into the dose rationale for medicines in humans, both in terms of efficacy and adverse events. Comparable benefits can be anticipated for the assessment of safety and toxicity profile of novel molecules. © The Author 2016. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Safety assessment and detection method of genetically modified Chinese Kale (Brassica oleracea cv. alboglabra ).

PubMed

Lin, Chih-Hui; Lu, Chien-Te; Lin, Hsin-Tang; Pan, Tzu-Ming

2009-03-11

Sporamins are tuberous storage proteins and account for 80% of soluble protein in sweet potato tubers with trypsin-inhibitory activity. The expression of sporamin protein in transgenic Chinese kale (line BoA 3-1) conferred insecticidal activity toward corn earworm [ Helicoverpa armigera (Hubner)] in a previous report. In this study, we present a preliminary safety assessment of transgenic Chinese kale BoA 3-1. Bioinformatic and simulated gastric fluid (SGF) analyses were performed to evaluate the allergenicity of sporamin protein. The substantial equivalence between transgenic Chinese kale and its wild-type host has been demonstrated by the comparison of important constituents. A reliable real-time polymerase chain reaction (PCR) detection method was also developed to control sample quality. Despite the results of most evaluations in this study being negative, the safety of sporamin in transgenic Chinese kale BoA 3-1 was uncluded because of the allergenic risk revealed by bioinformatic analysis.

A qualitative evaluation of fire safety education programs for older adults.

PubMed

Diekman, Shane T; Stewart, Tamara A; Teh, S Leesia; Ballesteros, Michael F

2010-03-01

This article presents a qualitative evaluation of six fire safety education programs for older adults delivered by public fire educators. Our main aims were to explore how these programs are implemented and to determine important factors that may lead to program success, from the perspectives of the public fire educators and the older adults. For each program, we interviewed the public fire educator(s), observed the program in action, and conducted focus groups with older adults attending the program. Analysis revealed three factors that were believed to facilitate program success (established relationships with the older adult community, rapport with older adult audiences, and presentation relevance) as well as three challenges (lack of a standardized curriculum and program implementation strategies, attendance difficulties, and physical limitations due to age). More fire safety education should be developed for older adult populations. For successful programs, public fire educators should address the specific needs of their local older adult community.

Implementation of non-condensable gases condensation suppression model into the WCOBRA/TRAC-TF2 LOCA safety evaluation code

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liao, J.; Cao, L.; Ohkawa, K.

2012-07-01

The non-condensable gases condensation suppression model is important for a realistic LOCA safety analysis code. A condensation suppression model for direct contact condensation was previously developed by Westinghouse using first principles. The model is believed to be an accurate description of the direct contact condensation process in the presence of non-condensable gases. The Westinghouse condensation suppression model is further revised by applying a more physical model. The revised condensation suppression model is thus implemented into the WCOBRA/TRAC-TF2 LOCA safety evaluation code for both 3-D module (COBRA-TF) and 1-D module (TRAC-PF1). Parametric study using the revised Westinghouse condensation suppression model ismore » conducted. Additionally, the performance of non-condensable gases condensation suppression model is examined in the ACHILLES (ISP-25) separate effects test and LOFT L2-5 (ISP-13) integral effects test. (authors)« less

Genetic modification of hematopoietic cells using retroviral and lentiviral vectors: safety considerations for vector design and delivery into target cells.

PubMed

Dropulic, Boro

2005-07-01

The recent development of leukemia in three patients following retroviral vector gene transfer in hematopoietic stem cells, resulting in the death of one patient, has raised safety concerns for the use of integrating gene transfer vectors for human gene therapy. This review discusses these serious adverse events from the perspective of whether restrictions on vector design and vector-modified target cells are warranted at this time. A case is made against presently establishing specific restrictions for vector design and transduced cells; rather, their safety should be ascertained by empiric evaluation in appropriate preclinical models on a case-by-case basis. Such preclinical data, coupled with proper informed patient consent and a risk-benefit ratio analysis, provide the best available prospective evaluation of gene transfer vectors prior to their translation into the clinic.

[Evaluation of the effectiveness of occupational safety and health inspections of construction sites in the Piedmont region from 2001 to 2005].

PubMed

Bruno, Santina; Bena, Antonella; Debernardi, Maria Luisa; Nava, S; Pastore, Raffaella; Proietti, C; Quarta, D

2009-01-01

To assess the effectiveness of safety inspections in the construction industry in Piedmont in terms of exposure to risk and injuries. We conducted a retrospective analysis of the surveillance activities carried out in Piedmont between 2001 and 2005: to this purpose, we used a logical framework and we identified indicators to evaluate the process and its impact on exposure and injuries. fixed standards involving the number of safety inspections and the type of constructions under control were respected; there was always sufficient diversity among the public works under control, although local health units used different working methods. Impact on exposure and injuries: injury rates in the construction industry in Piedmont showed a decreasing trend and systematically lower values compared to national rates. Injury rates in the "roads and railways" sector showed an increasing trend owing to the great number of public works under construction. In this case, the effect of preventive measures seems less noticeable, but this mainly depends on methodological limits, such as mismatch between numerator and denominator, difficulties in estimating the number of workers actually present on the sites, underreporting of minor events. Despite the limitations of a retrospective analysis, the Piedmont safety inspection programme for the construction industry showed coherence with the objectives and had a positive impact on injury rates.

[The role of safety climate and the relationship with job satisfaction: an exploratory study across three different occupational contexts.

PubMed

Emanuel, Federica; Colombo, Lara; Cortese, Claudio G; Ghislieri, Chiara

2017-12-01

This study examined the role of the "safety climate", or the organization's attention to health and safety of workers, and of job demand and resources in relation with job satisfaction. Wellbeing at work is a topic of growing interest, in line with the legislation and the programs on health and safety of workers and management and the evaluation of psychosocial risks. Several studies show that organizational actions concerning health and safety can be an indicator of the attention to employees' wellbeing, even if studies about the relationship between safety climate and some psychosocial outcomes are scant. The study analysed the relationship between job demand, job resources, safety climate and job satisfaction in three different occupational contexts (public authority, N = 224; social care organization, N = 115; pharmaceutical company, N = 127); workers were divided into groups based on the risk level appeared in the objective assessment of work-related stress, in order to identify differences. The self-report questionnaire gathered information about: job satisfaction, work efforts, supervisors' support, colleagues support, safety climate (α between .72 and .93). Data analysis provided: Cronbach α, analysis of variance, correlations, stepwise multiple regressions. The results showed that job satisfaction (R2 between .23 and .88) had a negative relationship with efforts and a positive relationship with job resources and safety climate. It emerges the importance of safety climate: to support and promote wellbeing at work, organizations could endorse training and information programs on health and safety for all workers and management, not only for professional groups with high-risk level. Future studies could explore the relation between safety climate and other outcomes, such as emotional exhaustion or objective indicators of organizational health (e.g. absenteeism, accidents, etc.). Copyright© by Aracne Editrice, Roma, Italy.

Insulation commonality assessment (phase 1). Volume 2: Section 7.0 through 16.0. [evaluation of materials used for spacecraft thermal insulation

NASA Technical Reports Server (NTRS)

1973-01-01

The heat transfer characteristics of various materials used for the thermal insulation of spacecraft are discussed. Techniques for conducting thermal performance analysis, structural performance analysis, and dynamic analysis are described. Processes for producing and finishing the materials are explained. The methods for determining reliability, system safety, materials tests, and design effectiveness are explained.

Online continuing education course enhances nutrition and health professionals' knowledge of food safety issues of high-risk populations.

PubMed

Wallner, Stephanie; Kendall, Patricia; Hillers, Virginia; Bradshaw, Eva; Medeiros, Lydia C

2007-08-01

To develop and evaluate the efficacy of an online continuing education course for professionals who provide food safety information to high-risk populations. A 2-credit graduate-level class was converted into six web-based modules (overview of foodborne illness, immunology, pregnancy, human immunodeficiency virus, cancer and transplants, and lifecycle) and offered to nutrition and health professionals. Participants had 8 weeks to complete the modules, pre and post questionnaires, and course evaluation. Those who successfully completed the protocol received six continuing education units from one of three professional associations. Change in knowledge was measured using pre and post questionnaires. Course efficacy was evaluated using a post-course questionnaire. A convenience sample of 140 registered dietitians/dietetic technicians registered, nurses, and extension educators were recruited through professional conferences and electronic mailing lists to take the course. Analysis of variance was used to evaluate differences in knowledge scores for all groups across five main effects (attempt, module, profession, age, and education). Course evaluation responses were used to assess course effectiveness. For each module, knowledge scores increased significantly (P<0.001) from pre to post questionnaire. Overall, knowledge scores increased from 67.3% before the modules to 91.9% afterwards. Course evaluation responses were favorable, and participants indicated that course objectives were met. Online continuing education courses, such as "Food Safety Issues for High Risk Populations," seem to be a convenient, effective option for dietetics professionals, nurses, and extension educators seeking knowledge about food safety issues of high-risk populations. Online learning is a promising delivery approach for the continuing education of health professionals.

Exploring the sociotechnical intersection of patient safety and electronic health record implementation

PubMed Central

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-01-01

Objective The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). Methods We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). Results The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human–computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. Discussion We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Conclusions Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology. PMID:24052536

Exploring the sociotechnical intersection of patient safety and electronic health record implementation.

PubMed

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-02-01

The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human-computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology.

The role of PRA in the safety assessment of VVER Nuclear Power Plants in Ukraine.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kot, C.

1999-05-10

Ukraine operates thirteen (13) Soviet-designed pressurized water reactors, VVERS. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs), in accordance with new SAR content requirements issued in September 1995, by the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine. The requirements are in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The last two requirements, on PRA and BDBA, are new, and the DBA requirements are an expanded version of the older SAR requirements. The US Departmentmore » of Energy (USDOE), as part of its Soviet-Designed Reactor Safety activities, is providing assistance and technology transfer to Ukraine to support their nuclear power plants (NPPs) in developing a Western-type technical basis for the new SARs. USDOE sponsored In-Depth Safety Assessments (ISAs) are in progress at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1, and a follow-on study has been initiated at Khmenytskyy Unit 1. The ISA projects encompass most areas of plant safety evaluation, but the initial emphasis is on performing a detailed, plant-specific Level 1 Internal Events PRA. This allows the early definition of the plant risk profile, the identification of risk significant accident sequences and plant vulnerabilities and provides guidance for the remainder of the safety assessments.« less

Safety evaluation model of urban cross-river tunnel based on driving simulation.

PubMed

Ma, Yingqi; Lu, Linjun; Lu, Jian John

2017-09-01

Currently, Shanghai urban cross-river tunnels have three principal characteristics: increased traffic, a high accident rate and rapidly developing construction. Because of their complex geographic and hydrological characteristics, the alignment conditions in urban cross-river tunnels are more complicated than in highway tunnels, so a safety evaluation of urban cross-river tunnels is necessary to suggest follow-up construction and changes in operational management. A driving risk index (DRI) for urban cross-river tunnels was proposed in this study. An index system was also constructed, combining eight factors derived from the output of a driving simulator regarding three aspects of risk due to following, lateral accidents and driver workload. Analytic hierarchy process methods and expert marking and normalization processing were applied to construct a mathematical model for the DRI. The driving simulator was used to simulate 12 Shanghai urban cross-river tunnels and a relationship was obtained between the DRI for the tunnels and the corresponding accident rate (AR) via a regression analysis. The regression analysis results showed that the relationship between the DRI and the AR mapped to an exponential function with a high degree of fit. In the absence of detailed accident data, a safety evaluation model based on factors derived from a driving simulation can effectively assess the driving risk in urban cross-river tunnels constructed or in design.

Pretest fracture evaluation of the NESC-1 spinning-cylinder experiment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Keeney, J.A.; Bass, B.R.; Williams, P.T.

This paper describes a pretest fracture analysis of the cylinder specimen being used in the Network for Evaluating Steel Components (NESC) large-scale spinning-cylinder project (NESC-1). Organized as an international forum to exchange information on procedures for structural integrity assessment, to collaborate on specific projects, and to promote the harmonization of international standards, the NESC is currently focusing on a research project funded by United Kingdom Health and Safety Executive (HSE) to study the total process of structural integrity assessments of aged reactor pressure vessels (RPVs) containing subclad cracks. The intent is to have the problem studied by a wide rangemore » of organizations involved in RPV safety assessment. In this project, important safety assessment issues are being investigated by inspection and analysis of a spinning cylinder test which was performed at the AEA Technology facility at Risley, UK. Thermoelastic-plastic analyses were carried out for a clad cylinder model with a 74-mm-deep through-clad inner-surface crack. For this loading, the analytical results indicate that cleavage initiation may be achieved. The intervention of warm prestressing and loss of constraint may make cleavage initiation difficult to achieve in the heat-affected zone (HAZ) and near-HAZ regions.« less

Occupational safety and health as an element of a complex compensation system evaluation within an organization.

PubMed

Beck-Krala, Ewa; Klimkiewicz, Katarzyna

2016-12-01

Occupational safety and health (OSH) plays a significant role in today's organizations, because it helps in attracting and retaining employees as well as molding their attitudes and behaviors at work. This is why the issue of OSH is stressed in a comprehensive approach to employee rewards: the total reward concept. This article explains how OSH may be included in a complex evaluation process of the compensation system. Although the literature on the effectiveness of employee compensation refers mainly to financial and non-financial components, there is a need for inclusion of working conditions in such analyses. An evaluation of the compensation system that incorporates OSH can drive many benefits for both the organization and employees. Obtaining such benefits, however, requires systematic evaluation of the reward system, including OSH. Incorporation of OSH issue within the comprehensive analysis of compensation systems promotes responsible behavior of all stakeholders.

Unmanned aircraft system sense and avoid integrity and continuity

NASA Astrophysics Data System (ADS)

Jamoom, Michael B.

This thesis describes new methods to guarantee safety of sense and avoid (SAA) functions for Unmanned Aircraft Systems (UAS) by evaluating integrity and continuity risks. Previous SAA efforts focused on relative safety metrics, such as risk ratios, comparing the risk of using an SAA system versus not using it. The methods in this thesis evaluate integrity and continuity risks as absolute measures of safety, as is the established practice in commercial aircraft terminal area navigation applications. The main contribution of this thesis is a derivation of a new method, based on a standard intruder relative constant velocity assumption, that uses hazard state estimates and estimate error covariances to establish (1) the integrity risk of the SAA system not detecting imminent loss of '"well clear," which is the time and distance required to maintain safe separation from intruder aircraft, and (2) the probability of false alert, the continuity risk. Another contribution is applying these integrity and continuity risk evaluation methods to set quantifiable and certifiable safety requirements on sensors. A sensitivity analysis uses this methodology to evaluate the impact of sensor errors on integrity and continuity risks. The penultimate contribution is an integrity and continuity risk evaluation where the estimation model is refined to address realistic intruder relative linear accelerations, which goes beyond the current constant velocity standard. The final contribution is an integrity and continuity risk evaluation addressing multiple intruders. This evaluation is a new innovation-based method to determine the risk of mis-associating intruder measurements. A mis-association occurs when the SAA system incorrectly associates a measurement to the wrong intruder, causing large errors in the estimated intruder trajectories. The new methods described in this thesis can help ensure safe encounters between aircraft and enable SAA sensor certification for UAS integration into the National Airspace System.

RISMC Toolkit and Methodology Research and Development Plan for External Hazards Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Coleman, Justin Leigh

This report includes the description and development plan for a Risk Informed Safety Margins Characterization (RISMC) toolkit and methodology that will evaluate multihazard risk in an integrated manner to support the operating nuclear fleet.

75 FR 57024 - Decision To Evaluate a Petition To Designate a Class of Employees From the Grand Junction...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

...: Grand Junction Operations Office. Location: Grand Junction, Colorado. Job Titles and/or Job Duties: All..., Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH...

77 FR 59615 - Decision To Evaluate a Petition To Designate a Class of Employees From the Mound Plant in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

...: Miamisburg, Ohio. Job Titles and/or Job Duties: All workers potentially exposed to radioactive materials..., Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and...

Preliminary finite element analysis of locomotive crashworthy components

DOT National Transportation Integrated Search

2011-09-21

The Office of Research and Development of the Federal Railroad Administration (FRA) and the Volpe Center are continuing to evaluate new technologies for increasing the safety of passengers and operators in rail equipment. In recognition of the import...

Field study evaluation of cepstrum coefficient speech analysis for fatigue in aviation cabin crew.

DOT National Transportation Integrated Search

2013-10-01

Impaired neurobehavioral performance induced by fatigue may compromise safety in 24-hr operational : environmentssuch as aviation. As such, non-invasive, reliable, and valid methods of objectively detecting : compromised performance capacity in opera...

Development of a Short Line Railroad Safety Institute : phase I - job analysis.

DOT National Transportation Integrated Search

2014-04-01

The Federal Railroad Administrations (FRA) : Office of Research and Development (R&D) is : supporting the American Short Line and : Regional Railroad Association (ASLRRA) in the : development, implementation, and evaluation of : a proposed Short L...

Toxicologic Pathology Forum Opinion Paper: Considerations for Toxicologic Pathologists Evaluating the Safety of Biomaterials and Finished Medical Devices.

PubMed

Gad, Shayne C; Schuh, JoAnn C L

2018-06-01

Safety ("biocompatibility") assessment of medical devices has evolved along a different path than that of drugs, being historically governed more by the considerations and needs of engineers rather than chemists and biologists. As a result, the involvement of veterinary pathologists has been much more limited-almost entirely to evaluating tissue responses in tissues in direct contact with implanted devices. As devices have become more complex in composition, structure, placement, and use, concerns as to adverse systemic responses in patients have called for more comprehensive and thoughtful evaluations of effects throughout the body. Further complexities arise from the increasing marriage of devices and drug/biologic therapeutics to achieve either better dose control and, specifically, in delivery to target organs/tissues or better tolerance of the body to medical devices (i.e., minimization of the foreign body response). The challenge to pathologists is to integrate in new technologies (such as in vivo imaging and immunology) and ways of viewing interactions with patient bodies. To fail to do so will allow the methods and standards for medical device safety evaluation to be based on chemical analysis and then the limited details inherent in literature-based risk assessments.

Context-aware system for pre-triggering irreversible vehicle safety actuators.

PubMed

Böhmländer, Dennis; Dirndorfer, Tobias; Al-Bayatti, Ali H; Brandmeier, Thomas

2017-06-01

New vehicle safety systems have led to a steady improvement of road safety and a reduction in the risk of suffering a major injury in vehicle accidents. A huge leap forward in the development of new vehicle safety systems are actuators that have to be activated irreversibly shortly before a collision in order to mitigate accident consequences. The triggering decision has to be based on measurements of exteroceptive sensors currently used in driver assistance systems. This paper focuses on developing a novel context-aware system designed to detect potential collisions and to trigger safety actuators even before an accident occurs. In this context, the analysis examines the information that can be collected from exteroceptive sensors (pre-crash data) to predict a certain collision and its severity to decide whether a triggering is entitled or not. A five-layer context-aware architecture is presented, that is able to collect contextual information about the vehicle environment and the actual driving state using different sensors, to perform reasoning about potential collisions, and to trigger safety functions upon that information. Accident analysis is used in a data model to represent uncertain knowledge and to perform reasoning. A simulation concept based on real accident data is introduced to evaluate the presented system concept. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Study on occupational safety climate in different types of enterprises and its relationship with occupational accidental injury].

PubMed

Liu, Xinxia; Huang, Guoxian; Wang, Shuyu; Guo, Zhiping; Zhou, Yuchao; Chen, Weiqing

2014-04-01

To evaluate the occupational safety climate in different types of enterprises and its relationship with occupational accidental injury. A cross-sectional survey based on self-report questionnaires was performed among 3311 front-line workers from 54 medium and small-sized manufacturing enterprises of different types in Zhongshan, China to investigate the socio-demographic characteristics, safety climate experience in workplace, and incidence of occupational accidental injury in the past year. Analysis of the data revealed that employees in different types of companies perceived different levels of safety climate, according to the scores on four subscales; the European and American enterprises had significantly better safety climate than the Hong Kong and Chinese private enterprises (P < 0.01). The self-reported rates of occupational injury were 3.38%, 4.76%, and 6.72%, respectively, for European and American, Hong Kong, and Chinese private enterprises (χ(2) = 6.78, P < 0.05). After control of such factors as age, sex, income, education level, and marriage, the logistic regression analysis showed that the risk of occupational accidental injury in the European and American enterprises was significantly lower than that in the Chinese private enterprises (OR = 0.57, 95%CI = 0.35-0.91). The type of enterprise influences the occupational safety climate and incidence of occupational injury among workers.

Factors associated with self-reported inattentive driving at highway-rail grade crossings.

PubMed

Zhao, Shanshan; Khattak, Aemal J

2017-12-01

This research identified factors associated with inattentive driving at Highway-Rail Grade Crossings (HRGCs) by investigating drivers' self-reported inattentive driving experiences and factors pertaining to their socioeconomic, personality, attitudinal, and other characteristics. A random selection of 2500 households in Nebraska received a survey questionnaire designed for licensed motor vehicle drivers; respondents returned 980 questionnaires. Factor analysis identified latent variables evaluating drivers' patience and inclination to wait for trains, attitudes toward new technology, law enforcement or education regarding HRGC safety, and the propensity to commit serious traffic violations at HRGCs. The investigation utilized a structural equation model for analysis. This model indicated that drivers with a higher risk of inattentive driving at HRGCs were: female, younger in age, from households with higher incomes, with shorter tenure (in years) in their current city of residence, more frequently used HRGCs, received less information on safety at HRGCs, had less patience to wait for trains to pass and had less interest in safety improvement technology, law enforcement or safety education at HRGCs. These research findings provide useful information for future research and to policy makers for improving public safety. Additionally, the results are useful for safety educational program providers for targeted program delivery to drivers that are more vulnerable to distracted driving at HRGCs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Integrated indicator to evaluate vehicle performance across: Safety, fuel efficiency and green domains.

PubMed

Torrao, G; Fontes, T; Coelho, M; Rouphail, N

2016-07-01

In general, car manufacturers face trade-offs between safety, efficiency and environmental performance when choosing between mass, length, engine power, and fuel efficiency. Moreover, the information available to the consumers makes difficult to assess all these components at once, especially when aiming to compare vehicles across different categories and/or to compare vehicles in the same category but across different model years. The main objective of this research was to develop an integrated tool able to assess vehicle's performance simultaneously for safety and environmental domains, leading to the research output of a Safety, Fuel Efficiency and Green Emissions (SEG) indicator able to evaluate and rank vehicle's performance across those three domains. For this purpose, crash data was gathered in Porto (Portugal) for the period 2006-2010 (N=1374). The crash database was analyzed and crash severity prediction models were developed using advanced logistic regression models. Following, the methodology for the SEG indicator was established combining the vehicle's safety and the environmental evaluation into an integrated analysis. The obtained results for the SEG indicator do not show any trade-off between vehicle's safety, fuel consumption and emissions. The best performance was achieved for newer gasoline passenger vehicles (<5year) with a smaller engine size (<1400cm(3)). According to the SEG indicator, a vehicle with these characteristics can be recommended for a safety-conscious profile user, as well as for a user more interested in fuel economy and/or in green performance. On the other hand, for larger engine size vehicles (>2000cm(3)) the combined score for safety user profile was in average more satisfactory than for vehicles in the smaller engine size group (<1400cm(3)), which suggests that in general, larger vehicles may offer extra protection. The achieved results demonstrate that the developed SEG integrated methodology can be a helpful tool for consumers to evaluate their vehicle selection through different domains (safety, fuel efficiency and green emissions). Furthermore, SEG indicator allows the comparison of vehicles across different categories and vehicle model years. Hence, this research is intended to support the decision-making process for transportation policy, safety and sustainable mobility, providing insights not only to policy makers, but also for general public guidance. Copyright © 2016 Elsevier Ltd. All rights reserved.

NASA Aviation Safety Program Weather Accident Prevention/weather Information Communications (WINCOMM)

NASA Technical Reports Server (NTRS)

Feinberg, Arthur; Tauss, James; Chomos, Gerald (Technical Monitor)

2002-01-01

Weather is a contributing factor in approximately 25-30 percent of general aviation accidents. The lack of timely, accurate and usable weather information to the general aviation pilot in the cockpit to enhance pilot situational awareness and improve pilot judgment remains a major impediment to improving aviation safety. NASA Glenn Research Center commissioned this 120 day weather datalink market survey to assess the technologies, infrastructure, products, and services of commercial avionics systems being marketed to the general aviation community to address these longstanding safety concerns. A market survey of companies providing or proposing to provide graphical weather information to the general aviation cockpit was conducted. Fifteen commercial companies were surveyed. These systems are characterized and evaluated in this report by availability, end-user pricing/cost, system constraints/limits and technical specifications. An analysis of market survey results and an evaluation of product offerings were made. In addition, recommendations to NASA for additional research and technology development investment have been made as a result of this survey to accelerate deployment of cockpit weather information systems for enhancing aviation safety.

Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

PubMed

Jarratt, Michael; Jones, Terry; Adelglass, Jeffrey; Bucko, Alicia; Pollak, Richard; Roman-Miranda, Amaury; Olin, Jason T; Swinyer, Leonard

2014-07-01

Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis. This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis. A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments. Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P< 0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle. This study was conducted in a relatively small population under controlled clinical trial conditions. Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.

Real-Time Safety Risk Assessment Based on a Real-Time Location System for Hydropower Construction Sites

PubMed Central

Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns. PMID:25114958

Real-time safety risk assessment based on a real-time location system for hydropower construction sites.

PubMed

Jiang, Hanchen; Lin, Peng; Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

Development of a lane change risk index using vehicle trajectory data.

PubMed

Park, Hyunjin; Oh, Cheol; Moon, Jaepil; Kim, Seongho

2018-01-01

Surrogate safety measures (SSMs) have been widely used to evaluate crash potential, which is fundamental for the development of effective safety countermeasures. Unlike existing SSMs, which are mainly focused on the evaluation of longitudinal vehicle maneuvering leading to rear-end crashes, this study proposes a new method for estimating crash risk while a subject vehicle changes lanes, referred to as the lane change risk index (LCRI). A novel feature of the proposed methodology is its incorporation of the amount of exposure time to potential crash and the expected crash severity level by applying a fault tree analysis (FTA) to the evaluation framework. Vehicle interactions between a subject vehicle and adjacent vehicles in the starting lane and the target lane are evaluated in terms of crash potential during lane change. Vehicle trajectory data obtained from a traffic stream, photographed using a drone flown over a freeway segment, is used to investigate the applicability of the proposed methodology. This study compares the characteristics of compulsory and discretionary lane changes observed in a work zone section and a general section of a freeway using the LCRI. It is expected that the outcome of this study will be valuable in evaluating the effectiveness of various traffic operations and control strategies in terms of lane change safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

A high-fidelity Monte Carlo evaluation of CANDU-6 safety parameters

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kim, Y.; Hartanto, D.

2012-07-01

Important safety parameters such as the fuel temperature coefficient (FTC) and the power coefficient of reactivity (PCR) of the CANDU-6 (CANada Deuterium Uranium) reactor have been evaluated by using a modified MCNPX code. For accurate analysis of the parameters, the DBRC (Doppler Broadening Rejection Correction) scheme was implemented in MCNPX in order to account for the thermal motion of the heavy uranium nucleus in the neutron-U scattering reactions. In this work, a standard fuel lattice has been modeled and the fuel is depleted by using the MCNPX and the FTC value is evaluated for several burnup points including the mid-burnupmore » representing a near-equilibrium core. The Doppler effect has been evaluated by using several cross section libraries such as ENDF/B-VI, ENDF/B-VII, JEFF, JENDLE. The PCR value is also evaluated at mid-burnup conditions to characterize safety features of equilibrium CANDU-6 reactor. To improve the reliability of the Monte Carlo calculations, huge number of neutron histories are considered in this work and the standard deviation of the k-inf values is only 0.5{approx}1 pcm. It has been found that the FTC is significantly enhanced by accounting for the Doppler broadening of scattering resonance and the PCR are clearly improved. (authors)« less

Assessing the 'system' in safe systems-based road designs: using cognitive work analysis to evaluate intersection designs.

PubMed

Cornelissen, M; Salmon, P M; Stanton, N A; McClure, R

2015-01-01

While a safe systems approach has long been acknowledged as the underlying philosophy of contemporary road safety strategies, systemic applications are sparse. This article argues that systems-based methods from the discipline of Ergonomics have a key role to play in road transport design and evaluation. To demonstrate, the Cognitive Work Analysis framework was used to evaluate two road designs - a traditional Melbourne intersection and a cut-through design for future intersections based on road safety safe systems principles. The results demonstrate that, although the cut-through intersection appears different in layout from the traditional intersection, system constraints are not markedly different. Furthermore, the analyses demonstrated that redistribution of constraints in the cut-through intersection resulted in emergent behaviour, which was not anticipated and could prove problematic. Further, based on the lack of understanding of emergent behaviour, similar design induced problems are apparent across both intersections. Specifically, incompatibilities between infrastructure, vehicles and different road users were not dealt with by the proposed design changes. The importance of applying systems methods in the design and evaluation of road transport systems is discussed. Copyright © 2013 Elsevier Ltd. All rights reserved.

Evaluation of an active learning module to teach hazard and risk in Hazard Analysis and Critical Control Points (HACCP) classes.

PubMed

Oyarzabal, Omar A; Rowe, Ellen

2017-04-01

The terms hazard and risk are significant building blocks for the organization of risk-based food safety plans. Unfortunately, these terms are not clear for some personnel working in food manufacturing facilities. In addition, there are few examples of active learning modules for teaching adult participants the principles of hazard analysis and critical control points (HACCP). In this study, we evaluated the effectiveness of an active learning module to teach hazard and risk to participants of HACCP classes provided by the University of Vermont Extension in 2015 and 2016. This interactive module is comprised of a questionnaire; group playing of a dice game that we have previously introduced in the teaching of HACCP; the discussion of the terms hazard and risk; and a self-assessment questionnaire to evaluate the teaching of hazard and risk. From 71 adult participants that completed this module, 40 participants (56%) provided the most appropriate definition of hazard, 19 participants (27%) provided the most appropriate definition of risk, 14 participants (20%) provided the most appropriate definitions of both hazard and risk, and 23 participants (32%) did not provide an appropriate definition for hazard or risk. Self-assessment data showed an improvement in the understanding of these terms (P < 0.05). Thirty participants (42%) stated that the most valuable thing they learned with this interactive module was the difference between hazard and risk, and 40 participants (65%) responded that they did not attend similar presentations in the past. The fact that less than one third of the participants answered properly to the definitions of hazard and risk at baseline is not surprising. However, these results highlight the need for the incorporation of modules to discuss these important food safety terms and include more active learning modules to teach food safety classes. This study suggests that active learning helps food personnel better understand important food safety terms that serve as building blocks for the understanding of more complex food safety topics.

Analysis of governmental Web sites on food safety issues: a global perspective.

PubMed

Namkung, Young; Almanza, Barbara A

2006-10-01

Despite a growing concern over food safety issues, as well as a growing dependence on the Internet as a source of information, little research has been done to examine the presence and relevance of food safety-related information on Web sites. The study reported here conducted Web site analysis in order to examine the current operational status of governmental Web sites on food safety issues. The study also evaluated Web site usability, especially information dimensionalities such as utility, currency, and relevance of content, from the perspective of the English-speaking consumer. Results showed that out of 192 World Health Organization members, 111 countries operated governmental Web sites that provide information about food safety issues. Among 171 searchable Web sites from the 111 countries, 123 Web sites (71.9 percent) were accessible, and 81 of those 123 (65.9 percent) were available in English. The majority of Web sites offered search engine tools and related links for more information, but their availability and utility was limited. In terms of content, 69.9 percent of Web sites offered information on foodborne-disease outbreaks, compared with 31.5 percent that had travel- and health-related information.

Development and applicability of Hospital Survey on Patient Safety Culture (HSOPS) in Japan.

PubMed

Ito, Shinya; Seto, Kanako; Kigawa, Mika; Fujita, Shigeru; Hasegawa, Toshihiko; Hasegawa, Tomonori

2011-02-07

Patient safety culture at healthcare organizations plays an important role in guaranteeing, improving and promoting overall patient safety. Although several conceptual frameworks have been proposed in the past, no standard measurement tool has yet been developed for Japan. In order to examine possibilities to introduce the Hospital Survey on Patient Safety Culture (HSOPS) in Japan, the authors of this study translated the HSOPS into Japanese, and evaluated its factor structure, internal consistency, and construct validity. Healthcare workers (n = 6,395) from 13 acute care general hospitals in Japan participated in this survey. Confirmatory factor analysis indicated that the Japanese HSOPS' 12-factor model was selected as the most pertinent, and showed a sufficiently high standard partial regression coefficient. The internal reliability of the subscale scores was 0.46-0.88. The construct validity of each safety culture sub-dimension was confirmed by polychoric correlation, and by an ordered probit analysis. The results of the present study indicate that the factor structures of the Japanese and the American HSOPS are almost identical, and that the Japanese HSOPS has acceptable levels of internal reliability and construct validity. This shows that the HSOPS can be introduced in Japan.

Toxic release consequence analysis tool (TORCAT) for inherently safer design plant.

PubMed

Shariff, Azmi Mohd; Zaini, Dzulkarnain

2010-10-15

Many major accidents due to toxic release in the past have caused many fatalities such as the tragedy of MIC release in Bhopal, India (1984). One of the approaches is to use inherently safer design technique that utilizes inherent safety principle to eliminate or minimize accidents rather than to control the hazard. This technique is best implemented in preliminary design stage where the consequence of toxic release can be evaluated and necessary design improvements can be implemented to eliminate or minimize the accidents to as low as reasonably practicable (ALARP) without resorting to costly protective system. However, currently there is no commercial tool available that has such capability. This paper reports on the preliminary findings on the development of a prototype tool for consequence analysis and design improvement via inherent safety principle by utilizing an integrated process design simulator with toxic release consequence analysis model. The consequence analysis based on the worst-case scenarios during process flowsheeting stage were conducted as case studies. The preliminary finding shows that toxic release consequences analysis tool (TORCAT) has capability to eliminate or minimize the potential toxic release accidents by adopting the inherent safety principle early in preliminary design stage. 2010 Elsevier B.V. All rights reserved.

Curriculum and Evaluation Guide for Safety Education Programs. Research and Evaluation Report Series No. 40.00.

ERIC Educational Resources Information Center

Lowry, Carlee S.

Designed to assist Bureau of Indian Affairs school officials in the identification of safety education program needs, this evaluation guide focuses upon the basic operational components in a safety education program. The means for establishing an evaluation design for safety education are presented via a flexible model appropriate for most…

The road against fatalities: infrastructure spending vs. regulation??

PubMed

Albalate, Daniel; Fernández, Laura; Yarygina, Anastasiya

2013-10-01

The road safety literature is typified by a high degree of compartmentalization between studies that focus on infrastructure and traffic conditions and those devoted to the evaluation of public policies and regulations. As a result, few studies adopt a unified empirical framework in their attempts at evaluating the road safety performance of public interventions, thus limiting our understanding of successful strategies in this regard. This paper considers both types of determinants in an analysis of a European country that has enjoyed considerable success in reducing road fatalities. After constructing a panel data set with road safety outcomes for all Spanish provinces between 1990 and 2009, we evaluate the role of the technical characteristics of infrastructure and recent infrastructure spending together with the main regulatory changes introduced. Our results show the importance of considering both types of determinants in a unified framework. Moreover, we highlight the importance of maintenance spending given its effectiveness in reducing fatalities and casualties in the current economic context of austerity that is having such a marked impact on investment efforts in Spain. Copyright © 2013 Elsevier Ltd. All rights reserved.

Mixed-Methods Evaluation of Real-Time Safety Reporting by Hospitalized Patients and Their Care Partners: The MySafeCare Application.

PubMed

Collins, Sarah A; Couture, Brittany; Smith, Ann DeBord; Gershanik, Esteban; Lilley, Elizabeth; Chang, Frank; Yoon, Cathy; Lipsitz, Stuart; Sheikh, Aziz; Benneyan, James; Bates, David W

2018-04-27

The aims of the study were to evaluate the amount and content of data patients and care partners reported using a real-time electronic safety tool compared with other reporting mechanisms and to understand their perspectives on safety concerns and reporting in the hospital. This study used mixed methods including 20-month preimplementation and postimplementation trial evaluating MySafeCare, a web-based application, which allows hospitalized patients/care partners to report safety concerns in real time. The study compared MySafeCare submission rates for three hospital units (oncology acute care, vascular intermediate care, medical intensive care) with submissions rates of Patient Family Relations (PFR) Department, a hospital service to address patient/family concerns. The study used triangulation of quantitative data with thematic analysis of safety concern submissions and patient/care partner interviews to understand submission content and perspectives on safety reporting. Thirty-two MySafeCare submissions were received with an average rate of 1.7 submissions per 1000 patient-days and a range of 0.3 to 4.8 submissions per 1000 patient-days across all units, indicating notable variation between units. MySafeCare submission rates were significantly higher than PFR submission rates during the postintervention period on the vascular unit (4.3 [95% confidence interval = 2.8-6.5] versus 1.5 [95% confidence interval = 0.7-3.1], Poisson) (P = 0.01). Overall trends indicated a decrease in PFR submissions after MySafeCare implementation. Triangulated data indicated patients preferred to report anonymously and did not want concerns submitted directly to their care team. MySafeCare evaluation confirmed the potential value of providing an electronic, anonymous reporting tool in the hospital to capture safety concerns in real time. Such applications should be tested further as part of patient safety programs.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Analysis of the Japanese subgroup in LEOPOLD II: a phase 2/3 study of BAY 81-8973, a new recombinant factor VIII product.

PubMed

Fujii, Teruhisa; Hanabusa, Hideji; Shima, Midori; Morinaga, Takeshi; Fukutake, Katsuyuki

2017-03-01

BAY 81-8973, a new full length recombinant FVIII product, has been developed for prophylaxis and on-demand therapy in patients with hemophilia A. LEOPOLD II was a phase 2/3 study comparing prophylaxis versus on-demand treatment with BAY 81-8973. The analysis herein evaluated the clinical profile in Japanese subjects enrolled in LEOPOLD II. The LEOPOLD II was an open-label randomized crossover study. Our analysis evaluated the efficacy using the annualized bleeding rate, safety, and pharmacokinetics in Japanese subjects with severe hemophilia A enrolled in LEOPOLD II. The median annualized bleeding rate was 59.9/year in the on-demand group and 1.9/year in the prophylaxis group for Japanese subjects. There were no study drug-related adverse events in the Japanese subjects. None of the subjects developed FVIII inhibitors. There were no apparent clinical differences in efficacy, safety, and pharmacokinetics between the Japanese and the non-Japanese subjects. Data for the Japanese subjects showed annualized bleeding rates to be remarkably lower in the prophylaxis group compared to the on-demand group and that BAY 81-8973 exhibited a good safety profile and tolerability. These results were similar for the non-Japanese subjects. The results support adoption of BAY 81-8973 for treatment of Japanese subjects with severe hemophilia A.

Current treatment of gram-positive infections: focus on efficacy, safety, and cost minimalization analysis of teicoplanin.

PubMed

Crane, V S; Garabedian-Ruffalo, S M

1992-12-01

The current health care environment has had a significant impact on hospital Pharmacy and Therapeutics Committee formulary decisions. In evaluating a new therapy for formulary inclusion, a cost savings along with equivalent or an improvement in patient care and safety is optimal. Teicoplanin is an investigational glycopeptide antimicrobial agent with a spectrum of activity similar to vancomycin. Unlike vancomycin, however, teicoplanin has a long elimination half-life permitting administration once daily, and is well tolerated when given intramuscularly. In addition, teicoplanin is associated with a favorable safety profile. Red man syndrome does not appear to be a significant clinical problem. Results of our cost minimalization analysis using the average acquisition costs of vancomycin revealed that teicoplanin (400 mg), at an average acquisition cost of less than $28.46 when administered intravenously and $30.93 when administered intramuscularly, offers a clinically efficacious, safe, and less expensive alternative to vancomycin therapy.

[The safety data sheets of the paint and coatings sector: analysis of the items of most interest to health and safety in the workplace].

PubMed

Boniardi, Luca; Canti, Zulejka; Cantoni, Susanna; Fustinoni, Silvia

2014-07-15

The interlinked REACH-CLP regulations promote the sharing of knowledge regarding the risks and hazards of chemicals throughout the supply chain. The safety data sheet (SDS) is the main instrument to achieve this goal. to study 100 SDS of paints and coatings sector in order to highlight major criticisms related to health and safety of workers. Using the criteria prescribed by Regulation 453/2010/EC and preparing a suitable check list, some items of the sections 1 "Identification of the substance/mixture and of the company", 2 "Hazards identification", 3 "Composition/information on ingredients", the first part of section 7 "Precautions for safe handling", sections 8 "Exposure controls/personal protection" and 16 "Other information", were therefore evaluated for their appropriateness. Seven SDS were written in a foreign language and were excluded from further analysis. Of the remaining 93 SDS, only 23% had a proportion of adequate items greater than 80%, 49 % had adequate items between 60 and 80%, and 28% had less than 60% adequate items. The most critical sections were those relating to workers' safe handling and exposure controls and protection. In conclusion, from the analysis of SDS we found high percentages of inadequacy, especially in sections 7 and 8, the most relevant for the protection of the health and safety of workers.

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act---a Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway Safety Plan (SHSP) and incorporate data-driven approaches to prioritize and evaluate program outcomes: Failure to do so resulted in funding sanctioning. In conjunction with the legislation, research efforts have also been progressing toward the development of new safety analysis tools such as IHSDM (Interactive Highway Safety Design Model), SafetyAnalyst, and HSM (Highway Safety Manual). These software and analysis tools are comparatively more advanced in statistical theory and level of accuracy, and have a tendency to be more data intensive. A review of the 2009 five-percent reports and excerpts from the nationwide survey revealed astonishing facts about the continuing use of traditional methods including crash frequencies and rates for site selection and prioritization. The intense data requirements and statistical complexity of advanced safety tools are considered as a hindrance to their adoption. In this context, this research aims at identifying the data requirements and data availability for SafetyAnalyst and HSM by working with both the tools. This research sets the stage for working with the Empirical Bayes approach by highlighting some of the biases and issues associated with the traditional methods of selecting projects such as greater emphasis on traffic volume and regression-to-mean phenomena. Further, the not-so-obvious issue with shorter segment lengths, which effect the results independent of the methods used, is also discussed. The more reliable and statistically acceptable Empirical Bayes methodology requires safety performance functions (SPFs), regression equations predicting the relation between crashes and exposure for a subset of roadway network. These SPFs, specific to a region and the analysis period are often unavailable. Calibration of already existing default national SPFs to the state's data could be a feasible solution, but, how well the state's data is represented is a legitimate question. With this background, SPFs were generated for various classifications of segments in Georgia and compared against the national default SPFs used in SafetyAnalyst calibrated to Georgia data. Dwelling deeper into the development of SPFs, the influence of actual and estimated traffic data on the fit of the equations is also studied questioning the accuracy and reliability of traffic estimations. In addition to SafetyAnalyst, HSM aims at performing quantitative safety analysis. Applying HSM methodology to two-way two-lane rural roads, the effect of using multiple CMFs (Crash Modification Factors) is studied. Lastly, data requirements, methodology, constraints, and results are compared between SafetyAnalyst and HSM.

Safety assessment, detection and traceability, and societal aspects of genetically modified foods. European Network on Safety Assessment of Genetically Modified Food Crops (ENTRANSFOOD). Concluding remarks.

PubMed

Kuiper, H A; König, A; Kleter, G A; Hammes, W P; Knudsen, I

2004-07-01

The most important results from the EU-sponsored ENTRANSFOOD Thematic Network project are reviewed, including the design of a detailed step-wise procedure for the risk assessment of foods derived from genetically modified crops based on the latest scientific developments, evaluation of topical risk assessment issues, and the formulation of proposals for improved risk management and public involvement in the risk analysis process. Copyright 2004 Elsevier Ltd.

DOE Office of Scientific and Technical Information (OSTI.GOV)

LaSalle, F.R.; Golbeg, P.R.; Chenault, D.M.

For reactor and nuclear facilities, both Title 10, Code of Federal Regulations, Part 50, and US Department of Energy Order 6430.1A require assessments of the interaction of non-Safety Class 1 piping and equipment with Safety Class 1 piping and equipment during a seismic event to maintain the safety function. The safety class systems of nuclear reactors or nuclear facilities are designed to the applicable American Society of Mechanical Engineers standards and Seismic Category 1 criteria that require rigorous analysis, construction, and quality assurance. Because non-safety class systems are generally designed to lesser standards and seismic criteria, they may become missilesmore » during a safe shutdown earthquake. The resistance of piping, tubing, and equipment to seismically generated missiles is addressed in the paper. Gross plastic and local penetration failures are considered with applicable test verification. Missile types and seismic zones of influence are discussed. Field qualification data are also developed for missile evaluation.« less

Application of modified extended method in CREAM for safety inspector in coal mines

NASA Astrophysics Data System (ADS)

Wang, Jinhe; Zhang, Xiaohong; Zeng, Jianchao

2018-01-01

Safety inspector often performs duties in circumstances contributes to the oc currence of human failures. Therefore, the paper aims at quantifying human failure pro bability (HFP) of safety inspector during the coal mine operation with cognitive reliabi lity and error analysis method (CREAM). Whereas, some shortcomings of this approa ch that lacking considering the applicability of the common performance condition (C PC), and the subjective of evaluating CPC level which weaken the accuracy of the qua ntitative prediction results. A modified extended method in CREAM which is able to a ddress these difficulties with a CPC framework table is proposed, and the proposed me thodology is demonstrated by the virtue of a coal-mine accident example. The results a re expected to be useful in predicting HFP of safety inspector and contribute to the enh ancement of coal mine safety.

Technical Report for Calculations of Atmospheric Dispersion at Onsite Locations for Department of Energy Nuclear Facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Levin, Alan; Chaves, Chris

2015-04-04

The Department of Energy (DOE) has performed an evaluation of the technical bases for the default value for the atmospheric dispersion parameter χ/Q. This parameter appears in the calculation of radiological dose at the onsite receptor location (co-located worker at 100 meters) in safety analysis of DOE nuclear facilities. The results of the calculation are then used to determine whether safety significant engineered controls should be established to prevent and/or mitigate the event causing the release of hazardous material. An evaluation of methods for calculation of the dispersion of potential chemical releases for the purpose of estimating the chemical exposuremore » at the co-located worker location was also performed. DOE’s evaluation consisted of: (a) a review of the regulatory basis for the default χ/Q dispersion parameter; (b) an analysis of this parameter’s sensitivity to various factors that affect the dispersion of radioactive material; and (c) performance of additional independent calculations to assess the appropriate use of the default χ/Q value.« less

Safety incentive and penalty provisions in Indian construction projects and their impact on safety performance.

PubMed

Hasan, Abid; Jha, Kumar Neeraj

2013-01-01

Safety incentive and penalty (I/P) provisions in construction contracts are one of the most common forms of I/P. Contradictory opinions on the effectiveness of these provisions have been expressed in the literature. Statistics on safety provisions were collected from 32 construction projects, which include both types of contracts - those with safety I/P provisions and those without them. Although inclusion of safety I/P provisions in contracts helps in improving the overall safety performance in construction projects, further scope for improvement still exists. Literature review and structured personal interviews, coupled with a survey based on preliminary questionnaire, revealed that successful formulation and implementation of such provisions are dependent on 25 attributes which need the attention of both clients and contractors. A questionnaire-based survey was conducted to evaluate these attributes. The six factors extracted by carrying out factor analysis are: incentive distribution method, proper labour training, special attention to risky situations, role of safety committee and sub-contractors, specialised works and safety equipments, and right form of I/P. If taken care of, these attributes have the potential to improve the safety performance in construction projects. The results would be useful to clients and contractors in implementing the safety I/P provisions and thereby improving safety performance.

Patient safety and infection control: bases for curricular integration.

PubMed

Silva, Andréa Mara Bernardes da; Bim, Lucas Lazarini; Bim, Felipe Lazarini; Sousa, Alvaro Francisco Lopes; Domingues, Pedro Castania Amadio; Nicolussi, Adriana Cristina; Andrade, Denise de

2018-05-01

To analyze curricular integration between teaching of patient safety and good infection prevention and control practices. Integrative review, designed to answer the question: "How does curricular integration of content about 'patient safety teaching' and content about 'infection prevention and control practices' occur in undergraduate courses in the health field?". The following databases were searched for primary studies: CINAHL, LILACS, ScienceDirect, Web of Science, Scopus, Europe PMC and MEDLINE. The final sample consisted of 13 studies. After content analysis, primary studies were grouped into two subject categories: "Innovative teaching practices" and "Curricular evaluation. Patient safety related to infection prevention and control practices is present in the curriculum of health undergraduate courses, but is not coordinated with other themes, is taught sporadically, and focuses mainly on hand hygiene.

SCALE TSUNAMI Analysis of Critical Experiments for Validation of 233U Systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mueller, Don; Rearden, Bradley T

2009-01-01

Oak Ridge National Laboratory (ORNL) staff used the SCALE TSUNAMI tools to provide a demonstration evaluation of critical experiments considered for use in validation of current and anticipated operations involving {sup 233}U at the Radiochemical Development Facility (RDF). This work was reported in ORNL/TM-2008/196 issued in January 2009. This paper presents the analysis of two representative safety analysis models provided by RDF staff.

Are there any differences in the efficacy and safety of different formulations of Oral 5-ASA used for induction and maintenance of remission in ulcerative colitis? evidence from cochrane reviews.

PubMed

Feagan, Brian G; Chande, Nilesh; MacDonald, John K

2013-08-01

We systematically reviewed and compared the efficacy and safety of oral mesalamine formulations (sustained release, delayed release, and prodrugs) used for induction and maintenance of remission in ulcerative colitis. The main objective of this review was to determine if there are any differences in efficacy or safety among the oral 5-ASA drugs. A literature search in February 2013 identified all applicable randomized trials. Study quality was evaluated using the Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation criteria were used to assess the overall quality of the evidence. Studies were subgrouped by common mesalamine comparators for meta-analysis. Studies were pooled for analysis if they compared equimolar doses of oral 5-ASA. Seventeen studies that evaluated 2925 patients were identified. The risk of bias was low for most factors, although 1 study was single blind and 3 were open label. No difference was observed between oral 5-ASA and comparator 5-ASA formulations in the proportion of patients with clinical remission (relative risk, 0.94; 95% confidence interval, 0.86-1.02), clinical improvement (relative risk, 0.89; 95% confidence interval, 0.77-1.01), or relapse at 12 months (relative risk, 1.01; 95% confidence interval, 0.80-1.28). Subgroup analyses showed no important differences in efficacy. No significant difference was demonstrated in rates of adverse events or withdrawal due to adverse events. There does not seem to be any difference in efficacy or safety among the various formulations of oral 5-ASA. Oral mesalamine is an effective and safe treatment of mild-to-moderate or quiescent ulcerative colitis regardless of the chosen formulation.

Predictors of Attitudes Toward Non-Technical Skills in Farming.

PubMed

Irwin, Amy; Poots, Jill

2018-01-01

Farming is a high-risk sector with up to 170,000 worldwide fatalities reported per year; it is therefore vital to identify methods of mitigating the dangers of this industry. Research within high-risk industries, such as aviation, shipping, and agriculture, has identified the importance of non-technical skills (NTS) in maintaining effective, safe performance and reducing error and injury. However, there is a lack of research evaluating factors that may contribute to NTS attitudes and behaviors. As a first step to address this literature gap, the current study evaluated a range of individual and environmental factors as potential predictors of attitudes toward NTS in agriculture. A sample of 170 farmers from within the United Kingdom and Ireland were surveyed using an online questionnaire. The questionnaire included measures of personality, stress, attitudes toward safety (safety climate, motivation, and risk), environmental stressors (workload, work-life imbalance), and non-technical skills (team and lone worker). Attitudes toward safety climate, compliance, and motivation showed a significant association with both team-based and lone worker NTS. Conscientiousness correlated positively with the majority of the NTS elements. Multiple regression analysis indicated neuroticism and conscientiousness demonstrated capacity to predict NTS attitudes. Concerns about costs and equipment, attitudes toward safety climate, and safety motivation were also found to be significant predictors of NTS attitudes. The results indicate the utility of individual characteristics and environmental factors when predicting farming NTS attitudes. As a result, these elements could be important when evaluating engagement with NTS and developing NTS training initiatives in agriculture.

Toward an understanding of the impact of production pressure on safety performance in construction operations.

PubMed

Han, Sanguk; Saba, Farzaneh; Lee, Sanghyun; Mohamed, Yasser; Peña-Mora, Feniosky

2014-07-01

It is not unusual to observe that actual schedule and quality performances are different from planned performances (e.g., schedule delay and rework) during a construction project. Such differences often result in production pressure (e.g., being pressed to work faster). Previous studies demonstrated that such production pressure negatively affects safety performance. However, the process by which production pressure influences safety performance, and to what extent, has not been fully investigated. As a result, the impact of production pressure has not been incorporated much into safety management in practice. In an effort to address this issue, this paper examines how production pressure relates to safety performance over time by identifying their feedback processes. A conceptual causal loop diagram is created to identify the relationship between schedule and quality performances (e.g., schedule delays and rework) and the components related to a safety program (e.g., workers' perceptions of safety, safety training, safety supervision, and crew size). A case study is then experimentally undertaken to investigate this relationship with accident occurrence with the use of data collected from a construction site; the case study is used to build a System Dynamics (SD) model. The SD model, then, is validated through inequality statistics analysis. Sensitivity analysis and statistical screening techniques further permit an evaluation of the impact of the managerial components on accident occurrence. The results of the case study indicate that schedule delays and rework are the critical factors affecting accident occurrence for the monitored project. Copyright © 2013 Elsevier Ltd. All rights reserved.

77 FR 34950 - Decision To Evaluate a Petition To Designate a Class of Employees From the Medina Facility in San...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

...: Medina Facility. Location: San Antonio, Texas. Job Titles and/or Job Duties: Workers potentially exposed... Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway...

75 FR 1622 - Decision To Evaluate a Petition To Designate a Class of Employees for the General Electric...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-12

...: Evendale, Ohio. Job Titles and/or Job Duties: All employees of the Department of Energy, its predecessor... Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway...

76 FR 70456 - Decision To Evaluate a Petition To Designate a Class of Employees From Brookhaven National...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

...: Upton, New York. Job Titles and/or Job Duties: All employees of the Department of Energy, its... Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway...

77 FR 6564 - Decision To Evaluate a Petition To Designate a Class of Employees From Nuclear Metals, Inc., West...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-08

.... Location: West Concord, Massachusetts. Job Titles and/or Job Duties: All employees. Period of Employment..., Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676...

76 FR 70456 - Decision To Evaluate a Petition To Designate a Class of Employees From Sandia National Laboratory...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

...: Albuquerque, New Mexico. Job Titles and/or Job Duties: All personnel who worked in any area. Period of..., Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and...

Research notes : evaluation of the oregon medically at-risk driver program.

DOT National Transportation Integrated Search

2009-05-01

Dr. James Strathman, a Portland State University researcher, recently completed an assessment of the safety risk of persons whose licenses were suspended under the Oregon Medically At-Risk Driver program. The results of the analysis suggested modific...

Finite element analysis and full-scale testing of locomotive crashworthy components

DOT National Transportation Integrated Search

2013-04-15

The Office of Research and Development of the Federal Railroad Administration (FRA) and the Volpe Center are continuing to evaluate new technologies for increasing the safety of passengers and operators in rail equipment. In recognition of the import...

Evaluation of the organisation and effectiveness of internal audits to govern patient safety in hospitals: a mixed-methods study

PubMed Central

van Gelderen, Saskia C; Zegers, Marieke; Boeijen, Wilma; Westert, Gert P; Robben, Paul B; Wollersheim, Hub C

2017-01-01

Objectives Hospital boards are legally responsible for safe healthcare. They need tools to assist them in their task of governing patient safety. Almost every Dutch hospital performs internal audits, but the effectiveness of these audits for hospital governance has never been evaluated. The aim of this study is to evaluate the organisation of internal audits and their effectiveness for hospitals boards to govern patient safety. Design and setting A mixed-methods study consisting of a questionnaire regarding the organisation of internal audits among all Dutch hospitals (n=89) and interviews with stakeholders regarding the audit process and experienced effectiveness of audits within six hospitals. Results Response rate of the questionnaire was 76% and 43 interviews were held. In every responding hospital, the internal audits followed the plan–do–check–act cycle. Every hospital used interviews, document analysis and site visits as input for the internal audit. Boards stated that effective aspects of internal audits were their multidisciplinary scope, their structured and in-depth approach, the usability to monitor improvement activities and to change hospital policy and the fact that results were used in meetings with staff and boards of supervisors. The qualitative methods (interviews and site visits) used in internal audits enable the identification of soft signals such as unsafe culture or communication and collaboration problems. Reported disadvantages were the low frequency of internal audits and the absence of soft signals in the actual audit reports. Conclusion This study shows that internal audits are regarded as effective for patient safety governance, as they help boards to identify patient safety problems, proactively steer patient safety and inform boards of supervisors on the status of patient safety. The description of the Dutch internal audits makes these audits replicable to other healthcare organisations in different settings, enabling hospital boards to complement their systems to govern patient safety. PMID:28698328

Safety evaluation of lane and shoulder width combinations on rural, two-lane, undivided roads

DOT National Transportation Integrated Search

2009-06-01

The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. The goal of this study is to evaluate the safety effectiveness of various lane...

Validation of tungsten cross sections in the neutron energy region up to 100 keV

NASA Astrophysics Data System (ADS)

Pigni, Marco T.; Žerovnik, Gašper; Leal, Luiz. C.; Trkov, Andrej

2017-09-01

Following a series of recent cross section evaluations on tungsten isotopes performed at Oak Ridge National Laboratory (ORNL), this paper presents the validation work carried out to test the performance of the evaluated cross sections based on lead-slowing-down (LSD) benchmarks conducted in Grenoble. ORNL completed the resonance parameter evaluation of four tungsten isotopes - 182,183,184,186W - in August 2014 and submitted it as an ENDF-compatible file to be part of the next release of the ENDF/B-VIII.0 nuclear data library. The evaluations were performed with support from the US Nuclear Criticality Safety Program in an effort to provide improved tungsten cross section and covariance data for criticality safety sensitivity analyses. The validation analysis based on the LSD benchmarks showed an improved agreement with the experimental response when the ORNL tungsten evaluations were included in the ENDF/B-VII.1 library. Comparison with the results obtained with the JEFF-3.2 nuclear data library are also discussed.

The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA.

PubMed Central

Chen, R. T.; DeStefano, F.; Davis, R. L.; Jackson, L. A.; Thompson, R. S.; Mullooly, J. P.; Black, S. B.; Shinefield, H. R.; Vadheim, C. M.; Ward, J. I.; Marcy, S. M.

2000-01-01

The Vaccine Safety Datalink is a collaborative project involving the National Immunization Program of the Centers for Disease Control and Prevention and several large health maintenance organizations in the USA. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. outpatient visits, emergency room visits, hospitalizations, and deaths) and covariates (e.g. birth certificates, census data) are prospectively collected and linked under joint protocol at multiple health maintenance organizations for analysis. Approximately 6 million persons (2% of the population of the USA) are now members of health maintenance organizations participating in the Vaccine Safety Datalink, which has proved to be a valuable resource providing important information on a number of vaccine safety issues. The databases and infrastructure created for the Vaccine Safety Datalink have also provided opportunities to address vaccination coverage, cost-effectiveness and other matters connected with immunization as well as matters outside this field. PMID:10743283

The economic burden of patient safety targets in acute care: a systematic review

PubMed Central

Mittmann, Nicole; Koo, Marika; Daneman, Nick; McDonald, Andrew; Baker, Michael; Matlow, Anne; Krahn, Murray; Shojania, Kaveh G; Etchells, Edward

2012-01-01

Background Our objective was to determine the quality of literature in costing of the economic burden of patient safety. Methods We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: “costs and cost analysis,” “cost-effectiveness,” “cost,” and “financial management, hospital.” We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76). The quality of each costing study per patient safety target was also evaluated. Results We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39%) reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22,414. Conclusion There are wide variations in the estimates of economic burden due to differences in study methods and methodologic quality. Greater attention to methodologic standards for economic evaluations in patient safety is needed. PMID:23097615

Development of a software safety process and a case study of its use

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

Development of a multilevel health and safety climate survey tool within a mining setting.

PubMed

Parker, Anthony W; Tones, Megan J; Ritchie, Gabrielle E

2017-09-01

This study aimed to design, implement and evaluate the reliability and validity of a multifactorial and multilevel health and safety climate survey (HSCS) tool with utility in the Australian mining setting. An 84-item questionnaire was developed and pilot tested on a sample of 302 Australian miners across two open cut sites. A 67-item, 10 factor solution was obtained via exploratory factor analysis (EFA) representing prioritization and attitudes to health and safety across multiple domains and organizational levels. Each factor demonstrated a high level of internal reliability, and a series of ANOVAs determined a high level of consistency in responses across the workforce, and generally irrespective of age, experience or job category. Participants tended to hold favorable views of occupational health and safety (OH&S) climate at the management, supervisor, workgroup and individual level. The survey tool demonstrated reliability and validity for use within an open cut Australian mining setting and supports a multilevel, industry specific approach to OH&S climate. Findings suggested a need for mining companies to maintain high OH&S standards to minimize risks to employee health and safety. Future research is required to determine the ability of this measure to predict OH&S outcomes and its utility within other mine settings. As this tool integrates health and safety, it may have benefits for assessment, monitoring and evaluation in the industry, and improving the understanding of how health and safety climate interact at multiple levels to influence OH&S outcomes. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Probabilistic margin evaluation on accidental transients for the ASTRID reactor project

NASA Astrophysics Data System (ADS)

Marquès, Michel

2014-06-01

ASTRID is a technological demonstrator of Sodium cooled Fast Reactor (SFR) under development. The conceptual design studies are being conducted in accordance with the Generation IV reactor objectives, particularly in terms of improving safety. For the hypothetical events, belonging to the accidental category "severe accident prevention situations" having a very low frequency of occurrence, the safety demonstration is no more based on a deterministic demonstration with conservative assumptions on models and parameters but on a "Best-Estimate Plus Uncertainty" (BEPU) approach. This BEPU approach ispresented in this paper for an Unprotected Loss-of-Flow (ULOF) event. The Best-Estimate (BE) analysis of this ULOFt ransient is performed with the CATHARE2 code, which is the French reference system code for SFR applications. The objective of the BEPU analysis is twofold: first evaluate the safety margin to sodium boiling in taking into account the uncertainties on the input parameters of the CATHARE2 code (twenty-two uncertain input parameters have been identified, which can be classified into five groups: reactor power, accident management, pumps characteristics, reactivity coefficients, thermal parameters and head losses); secondly quantify the contribution of each input uncertainty to the overall uncertainty of the safety margins, in order to refocusing R&D efforts on the most influential factors. This paper focuses on the methodological aspects of the evaluation of the safety margin. At least for the preliminary phase of the project (conceptual design), a probabilistic criterion has been fixed in the context of this BEPU analysis; this criterion is the value of the margin to sodium boiling, which has a probability 95% to be exceeded, obtained with a confidence level of 95% (i.e. the M5,95percentile of the margin distribution). This paper presents two methods used to assess this percentile: the Wilks method and the Bootstrap method ; the effectiveness of the two methods is compared on the basis of 500 simulations performed with theCATHARE2 code. We conclude that, with only 100 simulations performed with the CATHARE2 code, which is a number of simulations workable in the conceptual design phase of the ASTRID project where the models and the hypothesis are often modified, it is best in order to evaluate the percentile M5,95 of the margin to sodium boiling to use the bootstrap method, which will provide a slightly conservative result. On the other hand, in order to obtain an accurate estimation of the percentileM5,95, for the safety report for example, it will be necessary to perform at least 300 simulations with the CATHARE2 code. In this case, both methods (Wilks and Bootstrap) would give equivalent results.

Validation of a Preclinical Spinal Safety Model: Effects of Intrathecal Morphine in the Neonatal Rat

PubMed Central

Westin, B. David; Walker, Suellen M.; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L.

2010-01-01

Background Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long term function following intrathecal morphine in the neonatal rat. Methods Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P)3, 10 and 21. The relationship between injectate volume and segmental spread was assessed post mortem and by in-vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 minutes following intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis and glial response were evaluated 1 and 7 days following P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Results Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally-mediated analgesia at all ages with lower dose requirements in younger pups. High dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. Conclusions The therapeutic ratio for intrathecal morphine (toxic dose / antinociceptive dose) was at least 300 at P3, and at least 20 at P21 (latter doses limited by side effects). This data provides relative efficacy and safety data for comparison with other analgesic preparations and contributes supporting evidence for the validity of this preclinical neonatal safety model. PMID:20526189

Validation of a preclinical spinal safety model: effects of intrathecal morphine in the neonatal rat.

PubMed

Westin, B David; Walker, Suellen M; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L

2010-07-01

Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long-term function after intrathecal morphine in the neonatal rat. Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P) 3, 10, and 21. The relationship between injectate volume and segmental spread was assessed postmortem and by in vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 min after intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis, and glial response were evaluated 1 and 7 days after P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally mediated analgesia at all ages with lower dose requirements in younger pups. High-dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. The therapeutic ratio for intrathecal morphine (toxic dose/antinociceptive dose) was at least 300 at P3 and at least 20 at P21 (latter doses limited by side effects). These data provide relative efficacy and safety for comparison with other analgesic preparations and contribute supporting evidence for the validity of this preclinical neonatal safety model.

Thermal-hydraulic analysis capabilities and methods development at NYPA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Feltus, M.A.

1987-01-01

The operation of a nuclear power plant must be regularly supported by various thermal-hydraulic (T/H) analyses that may include final safety analysis report (FSAR) design basis calculations and licensing evaluations and conservative and best-estimate analyses. The development of in-house T/H capabilities provides the following advantages: (a) it leads to a better understanding of the plant design basis and operating characteristics; (b) methods developed can be used to optimize plant operations and enhance plant safety; (c) such a capability can be used for design reviews, checking vendor calculations, and evaluating proposed plant modifications; and (d) in-house capability reduces the cost ofmore » analysis. This paper gives an overview of the T/H capabilities and current methods development activity within the engineering department of the New York Power Authority (NYPA) and will focus specifically on reactor coolant system (RCS) transients and plant dynamic response for non-loss-of-coolant accident events. This paper describes NYPA experience in performing T/H analyses in support of pressurized water reactor plant operation.« less

Medical-device risk management and public safety: using cost-benefit as a measurement of effectiveness

NASA Astrophysics Data System (ADS)

Hughes, Allen A.

1994-12-01

Public safety can be enhanced through the development of a comprehensive medical device risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medical devices. The framework consists of the following sixteen attributes of a comprehensive medical device risk management system: fault/failure analysis, premarket testing/clinical trials, post-approval studies, manufacturer sponsored hospital studies, product labeling, establishment inspections, problem reporting program, mandatory hospital reporting, medical literature surveillance, device/patient registries, device performance monitoring, returned product analysis, autopsy program, emergency treatment funds/interim compensation, product liability, and alternative compensation mechanisms. Review of performance histories for several medical devices can reveal the value of information for many attributes, and also the inter-dependencies of the attributes in generating risk information flow. Such an information flow network is presented as a starting point for enhancing medical device risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.

Assessing the Congregate Disaster Shelter: Using Shelter Facility Assessment Data for Evaluating Potential Hazards to Occupants During Disasters.

PubMed

Cruz, Miguel A; Garcia, Stephanie; Chowdhury, Muhammad A B; Malilay, Josephine; Perea, Nancy; Williams, O Dale

Disaster shelter assessments are environmental health assessments conducted during disaster situations to evaluate the living environment of shelters for hygiene, sanitation, and safety conditions. We conducted a secondary data analysis of shelter assessment records available (n = 108) on ice storms, floods, and tornado events from 1 state jurisdiction. Descriptive statistics were used to analyze results of environmental health deficiencies found in the facilities. The greater numbers of environmental health deficiencies were associated with sanitation (26%), facility physical issues (19%), and food areas (17%). Most deficiencies were reported following ice storms, tornadoes, and flood events. This report describes the first analysis of environmental health deficiencies found in disaster shelters across a spectrum of disaster events. Although the number of records analyzed for this project was small and results may not be generalizable, this new insight into the living environment in shelter facilities offers the first analysis of deficiencies of the shelter operation and living environment that have great potential to affect the safety and health of shelter occupants.

Large-scale road safety programmes in low- and middle-income countries: an opportunity to generate evidence.

PubMed

Hyder, Adnan A; Allen, Katharine A; Peters, David H; Chandran, Aruna; Bishai, David

2013-01-01

The growing burden of road traffic injuries, which kill over 1.2 million people yearly, falls mostly on low- and middle-income countries (LMICs). Despite this, evidence generation on the effectiveness of road safety interventions in LMIC settings remains scarce. This paper explores a scientific approach for evaluating road safety programmes in LMICs and introduces such a road safety multi-country initiative, the Road Safety in 10 Countries Project (RS-10). By building on existing evaluation frameworks, we develop a scientific approach for evaluating large-scale road safety programmes in LMIC settings. This also draws on '13 lessons' of large-scale programme evaluation: defining the evaluation scope; selecting study sites; maintaining objectivity; developing an impact model; utilising multiple data sources; using multiple analytic techniques; maximising external validity; ensuring an appropriate time frame; the importance of flexibility and a stepwise approach; continuous monitoring; providing feedback to implementers, policy-makers; promoting the uptake of evaluation results; and understanding evaluation costs. The use of relatively new approaches for evaluation of real-world programmes allows for the production of relevant knowledge. The RS-10 project affords an important opportunity to scientifically test these approaches for a real-world, large-scale road safety evaluation and generate new knowledge for the field of road safety.

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

76 FR 454 - Hazardous Materials Transportation: Revisions of Special Permits Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-05

... the agency to evaluate the applicant's fitness and the safety impact of operations that would be... applicant granted a special permit undergoes a safety fitness evaluation, further assuring the safety of... operations to enable the agency to evaluate the applicant's fitness and the safety impact of operations that...

21 CFR 315.6 - Evaluation of safety.

Code of Federal Regulations, 2011 CFR

2011-04-01

... information, the following types of data: (i) Pharmacology data, (ii) Toxicology data, (iii) Clinical adverse... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

Authorization basis supporting documentation for plutonium finishing plant

DOE Office of Scientific and Technical Information (OSTI.GOV)

King, J.P., Fluor Daniel Hanford

1997-03-05

The identification and definition of the authorization basis for the Plutonium Finishing Plant (PFP) facility and operations are essential for compliance to DOE Order 5480.21, Unreviewed Safety Questions. The authorization basis, as defined in the Order, consists of those aspects of the facility design basis, i.e., the structures, systems and components (SSCS) and the operational requirements that are considered to be important to the safety of operations and are relied upon by DOE to authorize operation of the facility. These facility design features and their function in various accident scenarios are described in WHC-SD-CP-SAR-021, Plutonium Finishing Plant Final Safety Analysismore » Report (FSAR), Chapter 9, `Accident Analysis.` Figure 1 depicts the relationship of the Authorization Basis to its components and other information contained in safety documentation supporting the Authorization Basis. The PFP SSCs that are important to safety, collectively referred to as the `Safety Envelope` are discussed in various chapters of the FSAR and in WHC-SD-CP-OSR-010, Plutonium Finishing Plant Operational Safety Requirements. Other documents such as Criticality Safety Evaluation Reports (CSERS) address and support some portions of the Authorization Basis and Safety Envelope.« less

Local Food Systems Food Safety Concerns.

PubMed

Chapman, Benjamin; Gunter, Chris

2018-04-01

Foodborne disease causes an estimated 48 million illnesses and 3,000 deaths annually (Scallan E, et al., Emerg Infect Dis 17:7-15, 2011), with U.S. economic costs estimated at $152 billion to $1.4 trillion annually (Roberts T, Am J Agric Econ 89:1183-1188, 2007; Scharff RL, http://www.pewtrusts.org/en/research-and-analysis/reports/0001/01/01/healthrelated-costs-from-foodborne-illness-in-the-united-states, 2010). An increasing number of these illnesses are associated with fresh fruits and vegetables. An analysis of outbreaks from 1990 to 2003 found that 12% of outbreaks and 20% of outbreak-related illnesses were associated with produce (Klein S, Smith DeWaal CS, Center for Science in the Public Interest, https://cspinet.org/sites/default/files/attachment/ddreport.pdf, June 2008; Lynch M, Tauxe R, Hedberg C, Epidemiol Infect 137:307-315, 2009). These food safety problems have resulted in various stakeholders recommending the shift to a more preventative and risk-based food safety system. A modern risk-based food safety system takes a farm-to-fork preventative approach to food safety and relies on the proactive collection and analysis of data to better understand potential hazards and risk factors, to design and evaluate interventions, and to prioritize prevention efforts. Such a system focuses limited resources at the points in the food system with the likelihood of having greatest benefit to public health. As shared kitchens, food hubs, and local food systems such as community supported agriculture are becoming more prevalent throughout the United States, so are foodborne illness outbreaks at these locations. At these locations, many with limited resources, food safety methods of prevention are rarely the main focus. This lack of focus on food safety knowledge is why a growing number of foodborne illness outbreaks are occurring at these locations.

Safety assessment on pedestrian crossing environments using MLS data.

PubMed

Soilán, Mario; Riveiro, Belén; Sánchez-Rodríguez, Ana; Arias, Pedro

2018-02-01

In the framework of infrastructure analysis and maintenance in an urban environment, it is important to address the safety of every road user. This paper presents a methodology for the evaluation of several safety indicators on pedestrian crossing environments using geometric and radiometric information extracted from 3D point clouds collected by a Mobile Mapping System (MMS). The methodology is divided in four main modules which analyze the accessibility of the crossing area, the presence of traffic lights and traffic signs, and the visibility between a driver and a pedestrian on the proximities of a pedestrian crossing. The outputs of the analysis are exported to a Geographic Information System (GIS) where they are visualized and can be further processed in the context of city management. The methodology has been tested on approximately 30 pedestrian crossings in cluttered urban environments of two different cities. Results show that MMS are a valid mean to assess the safety of a specific urban environment, regarding its geometric conditions. Remarkable results are presented on traffic light classification, with a global F-score close to 95%. Copyright © 2017 Elsevier Ltd. All rights reserved.

Everolimus for Advanced Pancreatic Neuroendocrine Tumours: A Subgroup Analysis Evaluating Japanese Patients in the RADIANT-3 Trial

PubMed Central

Ito, Tetsuhide; Okusaka, Takuji; Ikeda, Masafumi; Igarashi, Hisato; Morizane, Chigusa; Nakachi, Kohei; Tajima, Takeshi; Kasuga, Akio; Fujita, Yoshie; Furuse, Junji

2012-01-01

Objective Everolimus, an inhibitor of the mammalian target of rapamycin, has recently demonstrated efficacy and safety in a Phase III, double-blind, randomized trial (RADIANT-3) in 410 patients with low- or intermediate-grade advanced pancreatic neuroendocrine tumours. Everolimus 10 mg/day provided a 2.4-fold improvement compared with placebo in progression-free survival, representing a 65% risk reduction for progression. The purpose of this analysis was to investigate the efficacy and safety of everolimus in the Japanese subgroup enrolled in the RADIANT-3 study. Methods Subgroup analysis of the Japanese patients was performed comparing efficacy and safety between everolimus 10 mg/day orally (n = 23) and matching placebo (n = 17). The primary endpoint was progression-free survival. Safety was evaluated on the basis of the incidence of adverse drug reactions. Results Progression-free survival was significantly prolonged with everolimus compared with placebo. The median progression-free survival was 19.45 months (95% confidence interval, 8.31–not available) with everolimus vs 2.83 months (95% confidence interval, 2.46–8.34) with placebo, resulting in an 81% risk reduction in progression (hazard ratio, 0.19; 95% confidence interval, 0.08–0.48; P< 0.001). Adverse drug reactions occurred in all 23 (100%) Japanese patients receiving everolimus and in 13 (77%) patients receiving placebo; most were grade 1/2 in severity. The most common adverse drug reactions in the everolimus group were rash (n = 20; 87%), stomatitis (n = 17; 74%), infections (n = 15; 65%), nail disorders (n = 12; 52%), epistaxis (n = 10; 44%) and pneumonitis (n = 10; 44%). Conclusions These results support the use of everolimus as a valuable treatment option for Japanese patients with advanced pancreatic neuroendocrine tumours. PMID:22859827

A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion.

PubMed

Barbanti Brodano, G; Griffoni, C; Zanotti, B; Gasbarrini, A; Bandiera, S; Ghermandi, R; Boriani, S

2015-10-01

Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion, because of its known osteoinductive and osteoconductive properties. Considering its autogenous origin, the use of ICBG has not been associated to an increase of intraoperative or postoperative complications directly related to the surgery. However, complications related to the harvesting procedure and to the donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. The family of ceramic-based bone grafts has been widely used and studied during the last years for spine surgical procedures in order to reduce the need for iliac crest bone grafting and the consequent morbidity associated to the harvesting procedures. We report here the results of a post-market surveillance analysis performed on four independent cohorts of patients (115 patients) to evaluate the safety of three different formulations of hydroxyapatite-derived products used as bone graft extenders/substitutes for lumbar arthrodesis. No intraoperative or post-operative complications related to the use of hydroxyapatite-derived products were detected, during medium and long follow up period (minimum 12 months-maximum 5 years). This post-market surveillance analysis evidenced the safety of ceramic products as bone graft extenders or substitutes for spine fusion. Moreover, the evidence of the safety of hydroxyapatite-derived products allows to perform clinical studies aimed at evaluating the fusion rates and the clinical outcomes of these materials as bone graft extenders/substitutes, in order to support their use as an alternative to ICBG for spine fusion.

Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion

PubMed Central

Weersink, Rianne A; Bouma, Margriet; Burger, David M; Drenth, Joost P H; Hunfeld, Nicole G M; Kranenborg, Minke; Monster-Simons, Margje H; van Putten, Sandra A W; Metselaar, Herold J; Taxis, Katja; Borgsteede, Sander D

2016-01-01

Introduction Liver cirrhosis can have a major impact on drug pharmacokinetics and pharmacodynamics. Patients with cirrhosis often suffer from potentially preventable adverse drug reactions. Guidelines on safe prescribing for these patients are lacking. The aim of this study is to develop a systematic method for evaluating the safety and optimal dosage of drugs in patients with liver cirrhosis. Methods and analysis For each drug, a six-step evaluation process will be followed. (1) Available evidence on the pharmacokinetics and safety of a drug in patients with liver cirrhosis will be collected from the Summary of Product Characteristics (SmPC) and a systematic literature review will be performed. (2) Data regarding two outcomes, namely pharmacokinetics and safety, will be extracted and presented in a standardised assessment report. (3) A safety classification and dosage suggestion will be proposed for each drug. (4) An expert panel will discuss the validity and clinical relevance of this suggested advice. (5) Advices will be implemented in all relevant Clinical Decision Support Systems in the Netherlands and published on a website for patients and healthcare professionals. (6) The continuity of the advices will be guaranteed by a yearly check of new literature and comments on the advices. This protocol will be applied in the evaluation of a selection of drugs: (A) drugs used to treat (complications of) liver cirrhosis, and (B) drugs frequently prescribed to the general population. Ethics and dissemination Since this study does not directly involve human participants, it does not require ethical clearance. Besides implementation on a website and in clinical decision support systems, we aim to publish the generated advices of one or two drug classes in a peer-reviewed journal and at conference meetings. PMID:27733414

Technical/commercial feasibility study of the production of fuel-grade ethanol from corn: 100-million-gallon-per-year production facility in Myrtle Grove, Louisiana

NASA Astrophysics Data System (ADS)

1982-05-01

The technical and economic feasibility of producing motor fuel alcohol from corn in a 100 million gallon per year plant to be constructed in Myrtle Grove, Louisiana is evaluated. The evaluation includes a detailed process design using proven technology, a capital cost estimate for the plant, a detailed analysis of the annual operating cost, a market study, a socioeconomic, environmental, health and safety analysis, and a complete financial analysis. Several other considerations for production of ethanol were evaluated including: cogeneration and fuel to be used in firing the boilers; single by-products vs. multiple by-products; and use of boiler flue gas for by-product drying.

Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

DTIC Science & Technology

2005-01-01

have the potential to become solid tools for manufacturers, purchasers, and consumers to evaluate patient safety issues in various health related...323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical

Nuclear criticality safety bounding analysis for the in-tank-precipitation (ITP) process, impacted by fissile isotopic weight fractions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bess, C.E.

The In-Tank Precipitation process (ITP) receives High Level Waste (HLW) supernatant liquid containing radionuclides in waste processing tank 48H. Sodium tetraphenylborate, NaTPB, and monosodium titanate (MST), NaTi{sub 2}O{sub 5}H, are added for removal of radioactive Cs and Sr, respectively. In addition to removal of radio-strontium, MST will also remove plutonium and uranium. The majority of the feed solutions to ITP will come from the dissolution of supernate that had been concentrated by evaporation to a crystallized salt form, commonly referred to as saltcake. The concern for criticality safety arises from the adsorption of U and Pt onto MST. If sufficientmore » mass and optimum conditions are achieved then criticality is credible. The concentration of u and Pt from solution into the smaller volume of precipitate represents a concern for criticality. This report supplements WSRC-TR-93-171, Nuclear Criticality Safety Bounding Analysis For The In-Tank-Precipitation (ITP) Process. Criticality safety in ITP can be analyzed by two bounding conditions: (1) the minimum safe ratio of MST to fissionable material and (2) the maximum fissionable material adsorption capacity of the MST. Calculations have provided the first bounding condition and experimental analysis has established the second. This report combines these conditions with canyon facility data to evaluate the potential for criticality in the ITP process due to the adsorption of the fissionable material from solution. In addition, this report analyzes the potential impact of increased U loading onto MST. Results of this analysis demonstrate a greater safety margin for ITP operations than the previous analysis. This report further demonstrates that the potential for criticality in the ITP process due to adsorption of fissionable material by MST is not credible.« less

U.S. Department of Energy Implementation of Chemical Evaluation Requirements for Transuranic Waste Disposal at the Waste Isolation Pilot Plant

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moon, Alison; Barkley, Michelle; Poppiti, James

This report summarizes new controls designed to ensure that transuranic waste disposed at the Waste Isolation Pilot Plant (WIPP) does not contain incompatible chemicals. These new controls include a Chemical Compatibility Evaluation, an evaluation of oxidizing chemicals, and a waste container assessment to ensure that waste is safe for disposal. These controls are included in the Chapter 18 of the Documented Safety Analysis for WIPP (1).

Using Space Syntax to Assess Safety in Public Areas - Case Study of Tarbiat Pedestrian Area, Tabriz-Iran

NASA Astrophysics Data System (ADS)

Cihangir Çamur, Kübra; Roshani, Mehdi; Pirouzi, Sania

2017-10-01

In studying the urban complex issues, simulation and modelling of public space use considerably helps in determining and measuring factors such as urban safety. Depth map software for determining parameters of the spatial layout techniques; and Statistical Package for Social Sciences (SPSS) software for analysing and evaluating the views of the pedestrians on public safety were used in this study. Connectivity, integration, and depth of the area in the Tarbiat city blocks were measured using the Space Syntax Method, and these parameters are presented as graphical and mathematical data. The combination of the results obtained from the questionnaire and statistical analysis with the results of spatial arrangement technique represents the appropriate and inappropriate spaces for pedestrians. This method provides a useful and effective instrument for decision makers, planners, urban designers and programmers in order to evaluate public spaces in the city. Prior to physical modification of urban public spaces, space syntax simulates the pedestrian safety to be used as an analytical tool by the city management. Finally, regarding the modelled parameters and identification of different characteristics of the case, this study represents the strategies and policies in order to increase the safety of the pedestrians of Tarbiat in Tabriz.

The Pennsylvania certified safety committee program: an evaluation of participation and effects on work injury rates.

PubMed

Liu, Hangsheng; Burns, Rachel M; Schaefer, Agnes G; Ruder, Teague; Nelson, Christopher; Haviland, Amelia M; Gray, Wayne B; Mendeloff, John

2010-08-01

Since 1994, Pennsylvania, like several other states, has provided a 5% discount on workers' compensation insurance premiums for firms with a certified joint labor management safety committee. This study explored the factors affecting program participation and evaluated the effect of this program on work injuries. Using Pennsylvania unemployment insurance data (1996-2006), workers' compensation data (1998-2005), and the safety committee audit data (1999-2007), we conducted propensity score matching and regression analysis on the program's impact on injury rates. Larger firms, firms with higher injury rates, firms in high risk industries, and firms without labor unions were more likely to join the safety committee program and less likely to drop out of the program. The injury rates of participants did not decline more than the rates for non-participants; however, rates at participant firms with good compliance dropped more than the rates at participant firms with poor compliance. Firm size and prior injury rates are key predictors of program participation. Firms that complied with the requirement to train their safety committee members did experience reductions in injuries, but non-compliance with that and other requirements was so widespread that no overall impact of the program could be detected. Copyright 2010 Wiley-Liss, Inc.

Safety analysis of sofosbuvir and ledipasvir for treating hepatitis C.

PubMed

Fazel, Yousef; Lam, Brian; Golabi, Pegah; Younossi, Zobair

2015-08-01

The approval of sofosbuvir (SOF), a nucleotide analogue NS5B polymerase inhibitor, and ledipasvir (LDV), a NS5A inhibitor, marked a new chapter in IFN and ribavirin-free treatment of hepatitis C virus (HCV). This drug reduces adverse events associated with IFN therapy. The purpose of this paper is to evaluate the safety and efficacy of LDV/SOF. Clinical trials illustrating safety and efficacy of LDV/SOF are reviewed and compared to other IFN and ribavirin-free treatment options available. In trials enrolling more than 3000 patients, LDV/SOF is well tolerated with a good safety and side-effect profile in diverse cohorts, including previous direct-acting antiviral (DAA) treatment failures, liver transplant recipients, decompensated cirrhosis and HIV/HCV co-infection. As with all DAAs, the potential for drug-drug interactions must be carefully evaluated, as demonstrated by recent post-marketing reports of symptomatic bradycardia when LDV/SOF is co-administered with amiodarone. Currently, dose recommendations cannot be given for patients with advanced renal disease. Trials in this population are ongoing, more study is warranted. When surveying the DAA regimens available, efficacy, safety and tolerability of LDV/SOF is comparable or better, and LDV/SOF provides an option with convenient single-tablet, once daily, ribavirin-free dosing with relatively few significant drug-drug interactions.

Track lateral shift : fundamentals and state-of-the-art review

DOT National Transportation Integrated Search

1996-02-01

This report presents a review of the state of the art of track lateral shift analysis, with improved concepts for safety evaluation of high speed trains generating track shift forces. The mechanics of track shift and the resulting track failure modes...

Data available on the impact of drug use on transportation safety

DOT National Transportation Integrated Search

1988-05-01

The report assesses the available data on drug use in transportation, the relevant experimental research on the impacts of drugs, and the state-of-the-art in drug analysis and toxicological quality control. The report describes and evaluates: informa...

77 FR 29644 - Decision To Evaluate a Petition To Designate a Class of Employees From the Hanford Site in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

...: Richland, Washington. Job Titles and/or Job Duties: All employees of the Department of Energy, its... Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C-46...

76 FR 10899 - Decision To Evaluate a Petition To Designate a Class of Employees From the W.R. Grace and Company...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-28

..., Maryland. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment..., Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH...

75 FR 13542 - Decision To Evaluate a Petition To Designate a Class of Employees for the De Soto Facility in Los...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

... County, California. Job Titles and/or Job Duties: All employees of the Department of Energy, its... Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia...

75 FR 13542 - Decision To Evaluate a Petition To Designate a Class of Employees for the Downey Facility in Los...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

... County, California. Job Titles and/or Job Duties: All employees of the Department of Energy, [[Page 13543..., Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH...

77 FR 18248 - Decision To Evaluate a Petition To Designate a Class of Employees From the Winchester Engineering...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-27

...: Winchester, Massachusetts. Job Titles and/or Job Duties: All employees of the Department of Energy, its... Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C-46...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sprik, Samuel; Kurtz, Jennifer M; Ainscough, Christopher D

In this presentation, the National Renewable Energy Laboratory presented aggregated analysis results on the performance of existing hydrogen stations, including performance, operation, utilization, maintenance, safety, hydrogen quality, and cost. The U.S. Department of Energy funds technology validation work at NREL through its National Fuel Cell Technology Evaluation Center (NFCTEC).

Effects of Defensive Vehicle Handling on Novice Driver Safety : Phase 3. Data Analysis and Results

DOT National Transportation Integrated Search

2010-09-01

This project evaluates the effectiveness of a multistage driver education program for Montanas young : drivers. A total of 347 teenaged drivers who had completed high school driver education agreed to participate. : These drivers were randomly spl...

Evaluation of the Gateway Monument Demonstration Program: Safety, Economic and Social Impact Analysis

DOT National Transportation Integrated Search

2009-09-01

The Gateway Monument Demonstration Program (GMDP) facilitated the construction of freestanding structures or signage along roadways to communicate the name of a city, county or township to motorists. The GMDP spanned a four-year period, commencing on...

How to Make a Critical Analysis of Your Transportation System.

ERIC Educational Resources Information Center

Comeau, Lee F.

An outline of questions is provided for evaluating student transportation systems. Questions are listed under the following topics: board of education policy, legal compliance, routing, contract transportation, special transportation, finance, purchasing, personnel, safety, vehicles, garage, maintenance, insurance, and energy conservation. (MLF)

Another C3RS site improves safety at midterm

DOT National Transportation Integrated Search

2013-12-31

This report is part of a series of Research Results published to provide the public and goverment and industry decision makers with the evaluations findings. The findings here cover the midterm analysis of C3RS at one demonstration site (Site A...

Integrated corridor management initiative : demonstration phase evaluation, San Diego technical capability analysis test plan.

DOT National Transportation Integrated Search

1998-11-01

The purpose of this working paper is to present estimates of potential safety benefits resulting from full implementation of Intelligent Transportation Systems (ITS) in the United States. These estimates were derived by integrating results from a num...

Alternative methods for safety analysis and intervention for contracting commercial vehicles and drivers in Connecticut

DOT National Transportation Integrated Search

2012-06-01

This study evaluated Connecticuts current system for qualifying contractors for : the use of commercial vehicles on state contracts, identifies its impacts, and : makes recommendations on how the state should revise the current system. The : prima...

Use of the Means/Ends Test to Evaluate Public School Dress-Code Policies

ERIC Educational Resources Information Center

Workman, Jane E.; Studak, Cathryn M.

2008-01-01

The purpose of this article is to explain how a means/ends test can be adapted for the school environment. Public school officials can use a means/ends test to document an analysis of whether dress-code policies will be effective in diminishing risks to the health, safety, or morality of the school population. Elements of policy evaluation--ends,…

Incident reporting: Its role in aviation safety and the acquisition of human error data

NASA Technical Reports Server (NTRS)

Reynard, W. D.

1983-01-01

The rationale for aviation incident reporting systems is presented and contrasted to some of the shortcomings of accident investigation procedures. The history of the United State's Aviation Safety Reporting System (ASRS) is outlined and the program's character explained. The planning elements that resulted in the ASRS program's voluntary, confidential, and non-punitive design are discussed. Immunity, from enforcement action and misuse of the volunteered data, is explained and evaluated. Report generation techniques and the ASRS data analysis process are described; in addition, examples of the ASRS program's output and accomplishments are detailed. Finally, the value of incident reporting for the acquisition of safety information, particularly human error data, is explored.

[Awareness of dysphagia in Parkinson's disease].

PubMed

Bayés-Rusiñol, Àngels; Forjaz, Maria J; Ayala, Alba; Crespo, M de la Cruz; Prats, Anna; Valles, Esther; Petit, Cristina; Casanovas, Mercè; Garolera-Freixa, Maite

2011-12-01

In order to be able to assess the level of awareness of swallowing disorders in Parkinson's disease (PD), a specific questionnaire was designed and validated: the Dysphapark questionnaire. A total of 470 persons with PD were asked whether they believe they have problems swallowing or not, and then they filled in a self-administered questionnaire that evaluates the effectiveness and safety of swallowing. The Dysphapark questionnaire was validated by means of Rasch analysis and classical psychometric methods. The safety and effectiveness dimensions of the Dysphapark fit the Rasch model well. The efficacy dimension showed significant differences for gender, length of the illness, awareness of dysphagia and length of meals. Significant differences were also found in the safety dimension for length and severity of illness, awareness of dysphagia, speech therapy and knowledge of thickening agents. Despite the fact that 90% of patients had problems concerning effectiveness and safety in swallowing, 79.45% were not aware that they suffered from dysphagia. The Dysphapark questionnaire is a suitable measure of dysphagia in PD, according to the Rasch analysis. A high proportion of patients with PD have dysphagia, although it has been observed that they have a low level of awareness of the condition, of the consequences it may have and of the possibility of using thickening agents. Given that some of the swallowing disorders in PD are asymptomatic and that the level of awareness of the disorder is low, we recommend including specific questionnaires as well as clinical and instrumental evaluation of dysphagia in clinical practice.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Roussel, G.

Leak-Before-Break (LBB) technology has not been applied in the first design of the seven Pressurized Water Reactors the Belgian utility is currently operating. The design basis of these plants required to consider the dynamic effects associated with the ruptures to be postulated in the high energy piping. The application of the LBB technology to the existing plants has been recently approved by the Belgian Safety Authorities but with a limitation to the primary coolant loop. LBB analysis has been initiated for the Doel 3 and Tihange 2 plants to allow the withdrawal of some of the reactor coolant pump snubbersmore » at both plants and not reinstall some of the restraints after steam generator replacement at Doel 3. LBB analysis was also found beneficial to demonstrate the acceptability of the primary components and piping to the new conditions resulting from power uprating and stretch-out operation. LBB analysis has been subsequently performed on the primary coolant loop of the Tihange I plant and is currently being performed for the Doel 4 plant. Application of the LBB to the primary coolant loop is based in Belgium on the U.S. Nuclear Regulatory Commission requirements. However the Belgian Safety Authorities required some additional analyses and put some restrictions on the benefits of the LBB analysis to maintain the global safety of the plant at a sufficient level. This paper develops the main steps of the safety evaluation performed by the Belgian Safety Authorities for accepting the application of the LBB technology to existing plants and summarizes the requirements asked for in addition to the U.S. Nuclear Regulatory Commission rules.« less

10 CFR 830.204 - Documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Documented safety analysis. 830.204 Section 830.204 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.204 Documented safety analysis... approval from DOE for the methodology used to prepare the documented safety analysis for the facility...

'It's a cultural expectation...' The pressure on medical trainees to work independently in clinical practice.

PubMed

Kennedy, Tara J T; Regehr, Glenn; Baker, G Ross; Lingard, Lorelei A

2009-07-01

Medical trainees demonstrate a reluctance to ask for help unless they believe it is absolutely necessary, a situation which could impact on the safety of patients. This study aimed to develop a theoretical exploration of the pressure on medical trainees to be independent and to generate theory-based approaches to the implications for patient safety of this pressure towards independent working. In Phase 1, 88 teaching team members from internal and emergency medicine were observed during clinical activities (216 hours), and 65 participants completed brief interviews. In Phase 2, 36 in-depth interviews were conducted using video vignettes. Data collection and analysis employed grounded theory methodology. Participants conceived that the pressure towards independence in clinical work originated in trainees' desire to lay claim to the identity of a doctor (as a member of a group of autonomous high achievers), and in organisational issues such as heavy workloads and constant evaluations. The identity and organisational issues related to the pressure towards independence were explored through the lenses of established theories from education and psychology. Consideration of Lave and Wenger's situated learning theory suggests that giving attention to the 'independent doctor' ideal, through measures such as involving trainees when their supervisors ask for help, could impact the safety of teaching team practice. Amalberti et al.'s migration model explains how pressures to maximise productivity and individual gain may cause teaching teams to migrate beyond the boundaries of safe practice and suggests that managing triggers (such as workload and high-stakes evaluations) for violations of safe practice might improve safety. Implementation and evaluation of these theory-based approaches to the safety of teaching team practice would contribute to a better understanding of the links between trainee independence and patient safety.

Effect of Aspirin Coadministration on the Safety of Celecoxib, Naproxen, or Ibuprofen.

PubMed

Reed, Grant W; Abdallah, Mouin S; Shao, Mingyuan; Wolski, Kathy; Wisniewski, Lisa; Yeomans, Neville; Lüscher, Thomas F; Borer, Jeffrey S; Graham, David Y; Husni, M Elaine; Solomon, Daniel H; Libby, Peter; Menon, Venu; Lincoff, A Michael; Nissen, Steven E

2018-04-24

The safety of nonsteroidal anti-inflammatory drug (NSAID) and aspirin coadministration is uncertain. The aim of this study was to compare the safety of combining NSAIDs with low-dose aspirin. This analysis of the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) trial included 23,953 patients with osteoarthritis or rheumatoid arthritis at increased cardiovascular risk randomized to celecoxib, ibuprofen, or naproxen. The on-treatment population was used for this study. Outcomes included composite major adverse cardiovascular events, noncardiovascular death, gastrointestinal or renal events, and components of the composite. Cox proportional hazards models compared outcomes among NSAIDs stratified by aspirin use following propensity score adjustment. Kaplan-Meier analysis was used to compare the cumulative probability of events. When taken without aspirin, naproxen or ibuprofen had greater risk for the primary composite endpoint compared with celecoxib (hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.22 to 1.90, p <0.001; and HR: 1.81; 95% CI: 1.46 to 2.26; p <0.001, respectively). Compared with celecoxib, ibuprofen had more major adverse cardiovascular events (p < 0.05), and both ibuprofen and naproxen had more gastrointestinal (p < 0.001) and renal (p < 0.05) events. Taken with aspirin, ibuprofen had greater risk for the primary composite endpoint compared with celecoxib (HR: 1.27; 95% CI: 1.06 to 1.51; p < 0.01); this was not significantly higher with naproxen (HR: 1.18; 95% CI: 0.98 to 1.41; p = 0.08). Among patients on aspirin, major adverse cardiovascular events were similar among NSAIDs, and compared with celecoxib, ibuprofen had more gastrointestinal and renal events (p < 0.05), while naproxen had more gastrointestinal events (p < 0.05), without a difference in renal events. Similar results were seen on adjusted Kaplan-Meier analysis. Celecoxib has a more favorable overall safety profile than naproxen or ibuprofen when taken without aspirin. Adding aspirin attenuates the safety advantage of celecoxib, although celecoxib is still associated with fewer gastrointestinal events than ibuprofen or naproxen and fewer renal events than ibuprofen. (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen [PRECISION]; NCT00346216). Copyright © 2018 American College of Cardiology Foundation. All rights reserved.

Safety assessment of widely used fermented virgin coconut oil (Cocos nucifera) in Malaysia: Chronic toxicity studies and SAR analysis of the active components.

PubMed

Ibrahim, Ahmad H; Khan, Md Shamsuddin Sultan; Al-Rawi, Sawsan S; Ahamed, Mohamed B Khadeer; Majid, Aman Shah Bin Abdul; Al-Suede, Fouad Saleih R; Ji, Dan; Majid, Amin Malik Shah Abdul

2016-11-01

Fermented Virgin Coconut Oil (FVCO) is widely used in the Southeast Asia as food and traditional medicine. The objective of the present study is the evaluation of chronic safety of the commercialized FVCO of Malaysia and other Southeast Asian countries. A single dose of 5000 mg/kg of FVCO was administered orally in rats (each group, n = 5) for the acute toxicity study and 175, 550 and 2000 mg/kg for sub-chronic and chronic studies (each group, n = 10), respectively. The behavior, mortality, and body weight of the rats were assessed to determine the toxic effects of FVCO. The haematology, biochemistry and histopathology of the treated rats were evaluated. The treated rats were safe with the dose of 5000 mg/kg in acute, sub-chronic and chronic indication. Abnormal clinical signs and morphology (gross necroscopy), changes of organ weight, anomalous haematology and biochemistry indexes were not found in comparison with the control (p > 0.05). In general, food and water intake were higher in the treated rats related to control. It was concluded that the presence of the antioxidant active compounds of FVCO might be the reason of safety. The structure activity relationship (SAR) provides a comprehensive mechanism to determine the safety that is the presence of the electron donating phenolic groups, carbonyl groups, and carboxylic acid in the ortho and meta position of the aromatic rings. The SAR showed the antioxidant properties of myristic acid and lauric acid determined by GC-MS analysis. This result suggests the safety of FVCO for chronic use, nutritional activity that FVCO formulation complies the requirements of regulatory agencies. Copyright © 2016 Elsevier Inc. All rights reserved.

Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: results of a post-marketing surveillance study in Korea.

PubMed

Kim, Tae Heon; Lee, Sang Eun; Lee, Hahn-Ey; Lee, Kyu-Sung

2016-08-01

The aim of this study was to evaluate the safety and efficacy of fesoterodine fumarate (fesoterodine; Toviaz ) in Korean patients with overactive bladder (OAB) in routine clinical practice. This was an open-label, non-interventional, prospective, post-marketing surveillance study submitted to the Korean Ministry of Food and Drug Safety. A total of 3109 patients aged ≥18 years with OAB symptoms were prescribed flexible doses of fesoterodine at the investigator's discretion. Safety was assessed based upon the reporting of adverse events (AEs). Efficacy was evaluated on the basis of patient self-assessment using a bladder diary as well as on the basis of investigator assessment in terms of overall clinical efficacy. A final analysis was performed on 3107 (99.9%) and 2978 (95.8%) patients for safety and efficacy analysis, respectively. The mean treatment duration of fesoterodine was 83.2 days. The incidence of AEs was 8.5% (265/3107). Common AEs that accounted for more than 1.0% of the total AE incidence included dry mouth (5.4%, 168/3107), constipation (1.5%, 48/3107) and micturition disorder (1.1%, 35/3107). Mean episodes of urinary frequency, urgency, and urgency urinary incontinence (UUI) per 24 hours decreased by 4.0, 2.4, and 0.8, respectively (all p < 0.001). At the final follow-up visit, the investigators found improvement in clinical efficacy for the majority of patients (90.1%, 2684/2978). Limitations of this study include the observational study design and the relatively short treatment duration. These results suggest that fesoterodine is a well tolerated and effective treatment for Korean patients with OAB in routine clinical practice.

New oral anticoagulants in patients with cancer: current state of evidence.

PubMed

Sardar, Partha; Chatterjee, Saurav; Herzog, Eyal; Pekler, Gerald; Mushiyev, Savi; Pastori, Luciano J; Visco, Ferdinand; Aronow, Wilbert S

2015-01-01

Effectiveness of new oral anticoagulants (NOAC) in patients with cancer is not clearly defined. There remain concerns of doubtful benefit and chances of potential harm with newer agents. In this meta-analysis, we evaluated the efficacy and safety of NOAC in patients with cancer. PubMed, Cochrane Library, EMBASE, Web of Science, and CINAHL databases were searched from January 01, 2001 through February 28, 2013. Randomized controlled trials reporting efficacy and safety data of NOACs (rivaroxaban, dabigatran, and apixaban) with control (low-molecular-weight heparin/vitamin K antagonists/placebo) for patients with cancer were included. Primary efficacy outcome was venous thromboembolism (VTE) or VTE-related death, and primary safety outcome was clinically relevant bleeding. We used random-effects models. Six trials randomized 19,832 patients, and 1197 patients had cancer. Risk of VTE or VTE-related death was not significantly different with NOAC versus control [odds ratio (OR), 0.80; 95% confidence interval (CI), 0.39-1.65] in patients with cancer. Separate analysis for individual effects showed similar results for rivaroxaban (OR, 1.08; 95% CI, 0.60-1.94) and dabigatran (OR, 0.91; 95% CI, 0.21-3.91). Clinically relevant bleeding was not higher with NOAC compared with control (OR, 1.49; 95% CI, 0.82-2.71); individual effect of rivaroxaban showed similar results. No statistically significant difference of efficacy and safety with NOAC was found between patients with and without cancer. Rivaroxaban might be equally effective and safe as vitamin K antagonist in patients with cancer. Dabigatran is as effective as comparator; however, safety profile of dabigatran is unknown. Randomized trials of new anticoagulants specific to the cancer population are necessary, and NOAC also need to be evaluated against low-molecular-weight heparin.

Safety self-efficacy and safety performance: potential antecedents and the moderation effect of standardization.

PubMed

Katz-Navon, Tal; Naveh, Eitan; Stern, Zvi

2007-01-01

The purpose of this paper is to suggest a new safety self-efficacy construct and to explore its antecedents and interaction with standardization to influence in-patient safety. The paper used a survey of 161 nurses using a self-administered questionnaire over a 14-day period in two large Israeli general hospitals. Nurses answered questions relating to four safety self-efficacy antecedents: enactive mastery experiences; managers as safety role models; verbal persuasion; and safety priority, that relate to the perceived level of standardization and safety self-efficacy. Confirmatory factor analysis was used to assess the scale's construct validity. Regression models were used to test hypotheses regarding the antecedents and influence of safety self-efficacy. Results indicate that: managers as safety role models; distributing safety information; and priority given to safety, contributed to safety self-efficacy. Additionally, standardization moderated the effects of safety self-efficacy and patient safety such that safety self-efficacy was positively associated with patient safety when standardization was low rather than high. Hospital managers should be aware of individual motivations as safety self-efficacy when evaluating the potential influence of standardization on patient safety. Theoretically, the study introduces a new safety self-efficacy concept, and captures its antecedents and influence on safety performance. Also, the study suggests safety self-efficacy as a boundary condition for the influence of standardization on safety performance. Implementing standardization in healthcare is problematic because not all processes can be standardized. In this case, self-efficacy plays an important role in securing patient safety. Hence, safety self-efficacy may serve as a "substitute-for-standardization," by promoting staff behaviors that affect patient safety.

Comparative physicochemical evaluation of a marketed herbomineral formulation: naga bhasma.

PubMed

Garg, M; Das, S; Singh, G

2012-11-01

In the practice of Ayurveda, where herbomineral formulations are said to be made biocompatible through specific processes like Shodhana and Marana, the western medical science on the contrary has raised the safety concerns of these formulations in the recent past. In the present study, comparative physico-chemical analysis of Naga bhasma, a herbo-mineral preparation having a reputation of miraculous drug commonly used to treat several health disorders, was carried out using five marketed formulations through analytical methods like differential scanning calorimetry, X-ray difraction, thermogravimetric analysis, Fourier Transform infrared spectroscopy and also subjected for particle size analysis and estimation of trace and heavy metals to access the safety of these formulation. The results revealed variable observations regarding particle size, metal form and content of lead. The presence of free lead in five different formulations indicated towards the possible risk of severe side effects to the consumer. Present findings certainly put doubt over the safety of this formulation but at the same time, variation in the results with all five formulations also indicated that these formulations were not prepared as per the mentioned Ayurvedic text. Hence, enforcement of strict regulatory guidelines is strongly warranted before launching into the market. Further, a series of biological studies need to be conducted before taking any final verdict on the safety of this formulation.

Advancing Usability Evaluation through Human Reliability Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ronald L. Boring; David I. Gertman

2005-07-01

This paper introduces a novel augmentation to the current heuristic usability evaluation methodology. The SPAR-H human reliability analysis method was developed for categorizing human performance in nuclear power plants. Despite the specialized use of SPAR-H for safety critical scenarios, the method also holds promise for use in commercial off-the-shelf software usability evaluations. The SPAR-H method shares task analysis underpinnings with human-computer interaction, and it can be easily adapted to incorporate usability heuristics as performance shaping factors. By assigning probabilistic modifiers to heuristics, it is possible to arrive at the usability error probability (UEP). This UEP is not a literal probabilitymore » of error but nonetheless provides a quantitative basis to heuristic evaluation. When combined with a consequence matrix for usability errors, this method affords ready prioritization of usability issues.« less

[Pregnant women's food safety and nutritional status in Cartagena, Colombia 2011].

PubMed

López-Sáleme, Rossana; Díaz-Montes, Carmen E; Bravo-Aljuriz, Leidy; Londoño-Hio, Nataly P; Salguedo-Pájaro, Maireng del Carmen; Camargo-Marín, Casandra C; Osorio-Espitia, Eider

2012-01-01

Establishing an association between food safety and nutritional status in pregnant women in Cartagena. This was a cross-sectional study, using a sample of 413 pregnant women living in urban areas who were affiliated to healthcare-providing companies in Cartagena. A 95 % confidence level, 5 % error and 0.41 prevalence were used. they were stratified by proportional allocation; nutritional status was identified by anthropometric indicators plotted on a Rosso-Mardones nomogram and food safety was determined by a national survey of the situation. Stata 9.2 statistical software was used for a descriptive analysis of the data using frequencies, percentages, averages and standard deviations. The odds ratio (OR)* and p <0.05 significance level were estimated in bivariate analysis. Mean age was 24.3 years-old, 72.2 % were living with a partner and 52 % belonged to stratum 1; it was determined that 70.2 % had food safety. Regarding nutritional status, it was observed that 42 % had maintained appropriate weight during pregnancy. Food safety was not associated with nutritional status (OR 0.8; 0.5-1.3 95 %CI). A high percentage of pregnant women had altered nutritional status, tending towards deficit or towards increase reported as having food safety. This may have been because this study assessed food safety in relation to even though the pregnant women may have had food available, this did not guarantee that they consumed it in suitable quantities and/or quality, such aspects not having been evaluated in this study.

A comparison among four tract dilation methods of percutaneous nephrolithotomy: a systematic review and meta-analysis.

PubMed

Dehong, Cao; Liangren, Liu; Huawei, Liu; Qiang, Wei

2013-11-01

The purpose of this study was to evaluate the efficacy and safety of the Amplatz dilation (AD), metal telescopic dilation (MTD), balloon dilation (BD), and one-shot dilation (OSD) methods for tract dilation during percutaneous nephrolithotomy (PCNL). Relevant eligible studies were identified using three electronic databases (Medline, EMBASE, and Cochrane CENTRAL). Database acquisition and quality evaluation were independently performed by two reviewers. Efficacy (stone-free rate, surgical duration, and tract dilatation fluoroscopy time) and safety (transfusion rate and hemoglobin decrease) were evaluated using Review Manager 5.2. Four randomized controlled trials and eight clinical controlled trials involving 6,820 patients met the inclusion criteria. The pooled result from a meta-analysis showed statistically significant differences in tract dilatation fluoroscopy time and hemoglobin decrease between the OSD and MTD groups, which showed comparable stone-free and transfusion rates. Significant differences in transfusion rate were found between the BD and MTD groups. Among patients without previous open renal surgery, those who underwent BD exhibited a lower blood transfusion rate and a shorter surgical duration compared with those who underwent AD. The OSD technique is safer and more efficient than the MTD technique for tract dilation during PCNL, particularly in patients with previous open renal surgery, resulting in a shorter tract dilatation fluoroscopy time and a lesser decrease in hemoglobin. The efficacy and safety of BD are better than AD in patients without previous open renal surgery. The OSD technique should be considered for most patients who undergo PCNL therapy.

Application of Natural Language Processing and Network Analysis Techniques to Post-market Reports for the Evaluation of Dose-related Anti-Thymocyte Globulin Safety Patterns.

PubMed

Botsis, Taxiarchis; Foster, Matthew; Arya, Nina; Kreimeyer, Kory; Pandey, Abhishek; Arya, Deepa

2017-04-26

To evaluate the feasibility of automated dose and adverse event information retrieval in supporting the identification of safety patterns. We extracted all rabbit Anti-Thymocyte Globulin (rATG) reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) from the product's initial licensure in April 16, 1984 through February 8, 2016. We processed the narratives using the Medication Extraction (MedEx) and the Event-based Text-mining of Health Electronic Records (ETHER) systems and retrieved the appropriate medication, clinical, and temporal information. When necessary, the extracted information was manually curated. This process resulted in a high quality dataset that was analyzed with the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA) to explore the association of rATG dosing with post-transplant lymphoproliferative disorder (PTLD). Although manual curation was necessary to improve the data quality, MedEx and ETHER supported the extraction of the appropriate information. We created a final dataset of 1,380 cases with complete information for rATG dosing and date of administration. Analysis in PANACEA found that PTLD was associated with cumulative doses of rATG >8 mg/kg, even in periods where most of the submissions to FAERS reported low doses of rATG. We demonstrated the feasibility of investigating a dose-related safety pattern for a particular product in FAERS using a set of automated tools.

Supra-Additive Interaction of Docosahexaenoic Acid and Naproxen and Gastric Safety on the Formalin Test in Rats.

PubMed

Arroyo-Lira, Arlette Guadalupe; Rodríguez-Ramos, Fernando; Ortiz, Mario I; Castañeda-Hernández, Gilberto; Chávez-Piña, Aracely Evangelina

2017-11-01

Preclinical Research The aim of this work was to evaluate the effect of docosahexaenoic acid (DHA) on the pharmacokinetics and pharmacodynamics-nociception-of naproxen in rats, as well as to determine the gastric safety resulting from this combination versus naproxen alone. Female Wistar rats were orally administered DHA, naproxen or the DHA-naproxen mixture at fixed-ratio combination of 1:3. The antinociceptive effect was evaluated using the formalin test. The gastric injury was determined 3 h after naproxen administration. An isobolographic analysis was performed to characterize the antinociceptive interaction between DHA and naproxen. To determine the possibility of pharmacokinetic interactions, the oral bioavailability of naproxen was evaluated in presence and absence of oral DHA. The experimental effective dose ED 30 values (Zexp) were decreased from theoretical additive dose values (Zadd; P < 0.05). The isobolographic analysis showed that the combination exhibited supra-additive interaction. The oral administration of DHA increased the pharmacokinetic parameter AUC 0- t of naproxen (P < 0.05). Furthermore, the gastric damage induced by naproxen was abolished when this drug was combined with DHA. These data suggest that oral administration of DHA-naproxen combination induces gastric safety and supra-additive antinociceptive effect in the formalin test so that this combination could be useful to management of inflammatory pain. Drug Dev Res 78 : 332-339, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

A novel approach for evaluating the risk of health care failure modes.

PubMed

Chang, Dong Shang; Chung, Jenq Hann; Sun, Kuo Lung; Yang, Fu Chiang

2012-12-01

Failure mode and effects analysis (FMEA) can be employed to reduce medical errors by identifying the risk ranking of the health care failure modes and taking priority action for safety improvement. The purpose of this paper is to propose a novel approach of data analysis. The approach is to integrate FMEA and a mathematical tool-Data envelopment analysis (DEA) with "slack-based measure" (SBM), in the field of data analysis. The risk indexes (severity, occurrence, and detection) of FMEA are viewed as multiple inputs of DEA. The practicality and usefulness of the proposed approach is illustrated by one case of health care. Being a systematic approach for improving the service quality of health care, the approach can offer quantitative corrective information of risk indexes that thereafter reduce failure possibility. For safety improvement, these new targets of the risk indexes could be used for management by objectives. But FMEA cannot provide quantitative corrective information of risk indexes. The novel approach can surely overcome this chief shortcoming of FMEA. After combining DEA SBM model with FMEA, the two goals-increase of patient safety, medical cost reduction-can be together achieved.

[Examination of safety improvement by failure record analysis that uses reliability engineering].

PubMed

Kato, Kyoichi; Sato, Hisaya; Abe, Yoshihisa; Ishimori, Yoshiyuki; Hirano, Hiroshi; Higashimura, Kyoji; Amauchi, Hiroshi; Yanakita, Takashi; Kikuchi, Kei; Nakazawa, Yasuo

2010-08-20

How the maintenance checks of the medical treatment system, including start of work check and the ending check, was effective for preventive maintenance and the safety improvement was verified. In this research, date on the failure of devices in multiple facilities was collected, and the data of the trouble repair record was analyzed by the technique of reliability engineering. An analysis of data on the system (8 general systems, 6 Angio systems, 11 CT systems, 8 MRI systems, 8 RI systems, and the radiation therapy system 9) used in eight hospitals was performed. The data collection period assumed nine months from April to December 2008. Seven items were analyzed. (1) Mean time between failures (MTBF) (2) Mean time to repair (MTTR) (3) Mean down time (MDT) (4) Number found by check in morning (5) Failure generation time according to modality. The classification of the breakdowns per device, the incidence, and the tendency could be understood by introducing reliability engineering. Analysis, evaluation, and feedback on the failure generation history are useful to keep downtime to a minimum and to ensure safety.

Preliminary safety analysis of the Baita Bihor radioactive waste repository, Romania

DOE Office of Scientific and Technical Information (OSTI.GOV)

Little, Richard; Bond, Alex; Watson, Sarah

2007-07-01

A project funded under the European Commission's Phare Programme 2002 has undertaken an in-depth analysis of the operational and post-closure safety of the Baita Bihor repository. The repository has accepted low- and some intermediate-level radioactive waste from industry, medical establishments and research activities since 1985 and the current estimate is that disposals might continue for around another 20 to 35 years. The analysis of the operational and post-closure safety of the Baita Bihor repository was carried out in two iterations, with the second iteration resulting in reduced uncertainties, largely as a result taking into account new information on the hydrologymore » and hydrogeology of the area, collected as part of the project. Impacts were evaluated for the maximum potential inventory that might be available for disposal to Baita Bihor for a number of operational and postclosure scenarios and associated conceptual models. The results showed that calculated impacts were below the relevant regulatory criteria. In light of the assessment, a number of recommendations relating to repository operation, optimisation of repository engineering and waste disposals, and environmental monitoring were made. (authors)« less

Establishment of a New Quality Control and Vaccine Safety Test for Influenza Vaccines and Adjuvants Using Gene Expression Profiling

PubMed Central

Momose, Haruka; Mizukami, Takuo; Kuramitsu, Madoka; Takizawa, Kazuya; Masumi, Atsuko; Araki, Kumiko; Furuhata, Keiko; Yamaguchi, Kazunari; Hamaguchi, Isao

2015-01-01

We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine. PMID:25909814

Roles of safety climate and shift work on perceived injury risk: a multi-level analysis.

PubMed

Huang, Yueng-Hsiang; Chen, Jiu-Chiuan; DeArmond, Sarah; Cigularov, Konstantin; Chen, Peter Y

2007-11-01

This study evaluated the relationship between employees' work shift (i.e., day shift versus night shift) and perceptions of injury risk, and how the relationship is affected by company level safety climate and injury frequency. The results showed that night shift workers perceived a higher level of injury risk compared to day shift workers. Both company level safety climate and injury frequency played critical roles in predicting individual perceived work injury risk. Perception of injury risk of night shift workers was significantly lower when they perceived high-level rather than low-level safety climate. However, this pattern was not noticeable for day shift workers. These findings highlighted the importance of considering company level factors when attempting to understand the differences between day shift and night shift work on an individual's perception of injury risk.

NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

2011-01-01

System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual basis but to consider measures of aggregate safety risk and to ensure wherever possible that there be quantitative measures for evaluating how effective the controls are in reducing these aggregate risks. The term aggregate risk, when used in this handbook, refers to the accumulation of risks from individual scenarios that lead to a shortfall in safety performance at a high level: e.g., an excessively high probability of loss of crew, loss of mission, planetary contamination, etc. Without aggregated quantitative measures such as these, it is not reasonable to expect that safety has been optimized with respect to other technical and programmatic objectives. At the same time, it is fully recognized that not all sources of risk are amenable to precise quantitative analysis and that the use of qualitative approaches and bounding estimates may be appropriate for those risk sources. Second, the handbook stresses the necessity of developing confidence that the controls derived for the purpose of achieving system safety not only handle risks that have been identified and properly characterized but also provide a general, more holistic means for protecting against unidentified or uncharacterized risks. For example, while it is not possible to be assured that all credible causes of risk have been identified, there are defenses that can provide protection against broad categories of risks and thereby increase the chances that individual causes are contained. Third, the handbook strives at all times to treat uncertainties as an integral aspect of risk and as a part of making decisions. The term "uncertainty" here does not refer to an actuarial type of data analysis, but rather to a characterization of our state of knowledge regarding results from logical and physical models that approximate reality. Uncertainty analysis finds how the output parameters of the models are related to plausible variations in the input parameters and in the modeling assumptions. The evaluation of unrtainties represents a method of probabilistic thinking wherein the analyst and decision makers recognize possible outcomes other than the outcome perceived to be "most likely." Without this type of analysis, it is not possible to determine the worth of an analysis product as a basis for making decisions related to safety and mission success. In line with these considerations the handbook does not take a hazard-analysis-centric approach to system safety. Hazard analysis remains a useful tool to facilitate brainstorming but does not substitute for a more holistic approach geared to a comprehensive identification and understanding of individual risk issues and their contributions to aggregate safety risks. The handbook strives to emphasize the importance of identifying the most critical scenarios that contribute to the risk of not meeting the agreed-upon safety objectives and requirements using all appropriate tools (including but not limited to hazard analysis). Thereafter, emphasis shifts to identifying the risk drivers that cause these scenarios to be critical and ensuring that there are controls directed toward preventing or mitigating the risk drivers. To address these and other areas, the handbook advocates a proactive, analytic-deliberative, risk-informed approach to system safety, enabling the integration of system safety activities with systems engineering and risk management processes. It emphasizes how one can systematically provide the necessary evidence to substantiate the claim that a system is safe to within an acceptable risk tolerance, and that safety has been achieved in a cost-effective manner. The methodology discussed in this handbook is part of a systems engineering process and is intended to be integral to the system safety practices being conducted by the NASA safety and mission assurance and systems engineering organizations. The handbook posits that to conclude that a system is adequately safe, it is necessary to consider a set of safety claims that derive from the safety objectives of the organization. The safety claims are developed from a hierarchy of safety objectives and are therefore hierarchical themselves. Assurance that all the claims are true within acceptable risk tolerance limits implies that all of the safety objectives have been satisfied, and therefore that the system is safe. The acceptable risk tolerance limits are provided by the authority who must make the decision whether or not to proceed to the next step in the life cycle. These tolerances are therefore referred to as the decision maker's risk tolerances. In general, the safety claims address two fundamental facets of safety: 1) whether required safety thresholds or goals have been achieved, and 2) whether the safety risk is as low as possible within reasonable impacts on cost, schedule, and performance. The latter facet includes consideration of controls that are collective in nature (i.e., apply generically to broad categories of risks) and thereby provide protection against unidentified or uncharacterized risks.

Failing to Fix What is Found: Risk Accommodation in the Oil and Gas Industry.

PubMed

Stackhouse, Madelynn R D; Stewart, Robert

2017-01-01

The present program of research synthesizes the findings from three studies in line with two goals. First, the present research explores how the oil and gas industry is performing at risk mitigation in terms of finding and fixing errors when they occur. Second, the present research explores what factors in the work environment relate to a risk-accommodating environment. Study 1 presents a descriptive evaluation of high-consequence incidents at 34 oil and gas companies over a 12-month period (N = 873), especially in terms of those companies' effectiveness at investigating and fixing errors. The analysis found that most investigations were fair in terms of quality (mean = 75.50%), with a smaller proportion that were weak (mean = 11.40%) or strong (mean = 13.24%). Furthermore, most companies took at least one corrective action for high-consequence incidents, but few of these corrective actions were confirmed as having been completed (mean = 13.77%). In fact, most corrective actions were secondary interim administrative controls (e.g., having a safety meeting) rather than fair or strong controls (e.g., training, engineering elimination). Study 2a found that several environmental factors explain the 56.41% variance in safety, including management's disengagement from safety concerns, finding and fixing errors, safety management system effectiveness, training, employee safety, procedures, and a production-over-safety culture. Qualitative results from Study 2b suggest that a compliance-based culture of adhering to liability concerns, out-group blame, and a production-over-safety orientation may all impede safety effectiveness. © 2016 Society for Risk Analysis.

Development and psychometric testing of an instrument to measure safety climate perceptions in community pharmacy.

PubMed

Newham, Rosemary; Bennie, Marion; Maxwell, David; Watson, Anne; de Wet, Carl; Bowie, Paul

2014-12-01

A positive and strong safety culture underpins effective learning from patient safety incidents in health care, including the community pharmacy (CP) setting. To build this culture, perceptions of safety climate must be measured with context-specific and reliable instruments. No pre-existing instruments were specifically designed or suitable for CP within Scotland. We therefore aimed to develop a psychometrically sound instrument to measure perceptions of safety climate within Scottish CPs. The first stage, development of a preliminary instrument, comprised three steps: (i) a literature review; (ii) focus group feedback; and (iii) content validation. The second stage, psychometric testing, consisted of three further steps: (iv) a pilot survey; (v) a survey of all CP staff within a single health board in NHS Scotland; and (vi) application of statistical methods, including principal components analysis and calculation of Cronbach's reliability coefficients, to derive the final instrument. The preliminary questionnaire was developed through a process of literature review and feedback. This questionnaire was completed by staff in 50 CPs from the 131 (38%) sampled. 250 completed questionnaires were suitable for analysis. Psychometric evaluation resulted in a 30-item instrument with five positively correlated safety climate factors: leadership, teamwork, safety systems, communication and working conditions. Reliability coefficients were satisfactory for the safety climate factors (α > 0.7) and overall (α = 0.93). The robust nature of the technical design and testing process has resulted in the development of an instrument with sufficient psychometric properties, which can be implemented in the community pharmacy setting in NHS Scotland. © 2014 John Wiley & Sons, Ltd.

Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis

PubMed Central

Colombo, Delia; Zagni, Emanuela; Nica, Mihaela; Rizzoli, Sara; Ori, Alessandra; Bellia, Gilberto

2016-01-01

Background MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity. Methods Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ2 test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ2 test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ2 P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ2 P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males (χ2 test P=0.0246). Conclusion This safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials from a gender-specific perspective. PMID:27695289

Safe and effective nursing shift handover with NURSEPASS: An interrupted time series.

PubMed

Smeulers, Marian; Dolman, Christine D; Atema, Danielle; van Dieren, Susan; Maaskant, Jolanda M; Vermeulen, Hester

2016-11-01

Implementation of a locally developed evidence based nursing shift handover blueprint with a bedside-safety-check to determine the effect size on quality of handover. A mixed methods design with: (1) an interrupted time series analysis to determine the effect on handover quality in six domains; (2) descriptive statistics to analyze the intercepted discrepancies by the bedside-safety-check; (3) evaluation sessions to gather experiences with the new handover process. We observed a continued trend of improvement in handover quality and a significant improvement in two domains of handover: organization/efficiency and contents. The bedside-safety-check successfully identified discrepancies on drains, intravenous medications, bandages or general condition and was highly appreciated. Use of the nursing shift handover blueprint showed promising results on effectiveness as well as on feasibility and acceptability. However, to enable long term measurement on effectiveness, evaluation with large scale interrupted times series or statistical process control is needed. Copyright © 2016 Elsevier Inc. All rights reserved.

Development, fabrication and test of a high purity silica heat shield

NASA Technical Reports Server (NTRS)

Rusert, E. L.; Drennan, D. N.; Biggs, M. S.

1978-01-01

A highly reflective hyperpure ( 25 ppm ion impurities) slip cast fused silica heat shield material developed for planetary entry probes was successfully scaled up. Process development activities for slip casting large parts included green strength improvements, casting slip preparation, aggregate casting, strength, reflectance, and subscale fabrication. Successful fabrication of a one-half scale Saturn probe (shape and size) heat shield was accomplished while maintaining the silica high purity and reflectance through the scale-up process. However, stress analysis of this original aggregate slip cast material indicated a small margin of safety (MS. = +4%) using a factor of safety of 1.25. An alternate hyperpure material formulation to increase the strength and toughness for a greater safety margin was evaluated. The alternate material incorporates short hyperpure silica fibers into the casting slip. The best formulation evaluated has a 50% by weight fiber addition resulting in an 80% increase in flexural strength and a 170% increase in toughness over the original aggregate slip cast materials with comparable reflectance.

[Contemporary state of work conditions and occupational morbidity of workers engaged into rubber, mechanical rubber and tire industries].

PubMed

Stepanov, E G; Galiullina, É F; Samsonov, V M; Kudriavtsev, V P; Davletgareeva, G R; Shakirova, É D; Khasanov, B G; Buliakov, R T; Kamilov, R F; Shakirov, D F

2014-01-01

Based on analysis of materials provided by occupational safety department PC "UZEMiK" and JSC "Kauchuk", the authors evaluate contemporary work conditions and occupational morbidity in workers engaged into rubber, mechanical rubber and tyre industries.

77 FR 46439 - Decision To Evaluate a Petition To Designate a Class of Employees From the Baker Brothers Site in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-03

.... Location: Toledo, Ohio. Job Titles and/or Job Duties: All employees who worked in any area. Period of..., Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676...

75 FR 13543 - Decision To Evaluate a Petition To Designate a Class of Employees for the Simonds Saw and Steel...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

.... Location: Lockport, New York. Job Titles and/or Job Duties: All employees who worked in any area during the... Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia...

77 FR 12594 - Decision To Evaluate a Petition To Designate a Class of Employees From the Rocky Flats Plant in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

.... Location: Golden, Colorado. Job Titles and/or Job Duties: All employees of the Department of Energy, its... Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C-46...

Los Angeles congestion reduction demonstration (Metro ExpressLanes) program. National evaluation : content analysis test plan.

DOT National Transportation Integrated Search

1998-11-01

This flyer summarizes the identified human factors research needs for integrated in-vehicle systems for transit vehicles, one of five configurations of in-vehicle safety and driver information systems. A complete review of the research needs for all ...

14 CFR Appendix B to Part 415 - Safety Review Document Outline

Code of Federal Regulations, 2013 CFR

2013-01-01

....0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and... Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety Plan 4.3.1Flight Safety Personnel 4... Safety (§ 415.117) 5.1Ground Safety Analysis Report 5.2Ground Safety Plan 6.0Launch Plans (§ 415.119 and...

14 CFR Appendix B to Part 415 - Safety Review Document Outline

Code of Federal Regulations, 2014 CFR

2014-01-01

....0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and... Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety Plan 4.3.1Flight Safety Personnel 4... Safety (§ 415.117) 5.1Ground Safety Analysis Report 5.2Ground Safety Plan 6.0Launch Plans (§ 415.119 and...

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2010 CFR

2010-07-01

... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life... empirical tools should be used to support the life safety equivalency evaluation? 102-80.120 Section 102-80...

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2011 CFR

2011-01-01

... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life... empirical tools should be used to support the life safety equivalency evaluation? 102-80.120 Section 102-80...

An evaluation of computer-aided disproportionality analysis for post-marketing signal detection.

PubMed

Lehman, H P; Chen, J; Gould, A L; Kassekert, R; Beninger, P R; Carney, R; Goldberg, M; Goss, M A; Kidos, K; Sharrar, R G; Shields, K; Sweet, A; Wiholm, B E; Honig, P K

2007-08-01

To understand the value of computer-aided disproportionality analysis (DA) in relation to current pharmacovigilance signal detection methods, four products were retrospectively evaluated by applying an empirical Bayes method to Merck's post-marketing safety database. Findings were compared with the prior detection of labeled post-marketing adverse events. Disproportionality ratios (empirical Bayes geometric mean lower 95% bounds for the posterior distribution (EBGM05)) were generated for product-event pairs. Overall (1993-2004 data, EBGM05> or =2, individual terms) results of signal detection using DA compared to standard methods were sensitivity, 31.1%; specificity, 95.3%; and positive predictive value, 19.9%. Using groupings of synonymous labeled terms, sensitivity improved (40.9%). More of the adverse events detected by both methods were detected earlier using DA and grouped (versus individual) terms. With 1939-2004 data, diagnostic properties were similar to those from 1993 to 2004. DA methods using Merck's safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.

Negative Stress Margins - Are They Real?

NASA Technical Reports Server (NTRS)

Raju, Ivatury S.; Lee, Darlene S.; Mohaghegh, Michael

2011-01-01

Advances in modeling and simulation, new finite element software, modeling engines and powerful computers are providing opportunities to interrogate designs in a very different manner and in a more detailed approach than ever before. Margins of safety are also often evaluated using local stresses for various design concepts and design parameters quickly once analysis models are defined and developed. This paper suggests that not all the negative margins of safety evaluated are real. The structural areas where negative margins are frequently encountered are often near stress concentrations, point loads and load discontinuities, near locations of stress singularities, in areas having large gradients but with insufficient mesh density, in areas with modeling issues and modeling errors, and in areas with connections and interfaces, in two-dimensional (2D) and three-dimensional (3D) transitions, bolts and bolt modeling, and boundary conditions. Now, more than ever, structural analysts need to examine and interrogate their analysis results and perform basic sanity checks to determine if these negative margins are real.

Twenty-fifth water reactor safety information meeting: Proceedings. Volume 2: Human reliability analysis and human performance evaluation; Technical issues related to rulemakings; Risk-informed, performance-based initiatives; High burn-up fuel research

DOE Office of Scientific and Technical Information (OSTI.GOV)

Monteleone, S.

1998-03-01

This three-volume report contains papers presented at the conference. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Japan, Norway, and Russia. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. This volume contains the following: (1) human reliability analysis and human performance evaluation; (2) technical issues relatedmore » to rulemakings; (3) risk-informed, performance-based initiatives; and (4) high burn-up fuel research. Selected papers have been indexed separately for inclusion in the Energy Science and Technology Database.« less

High Content Analysis technology for evaluating the joint toxicity of sunset yellow and sodium sulfite in vitro.

PubMed

Qu, Daofeng; Gu, Yanpei; Feng, Lifang; Han, Jianzhong

2017-10-15

Foods contain various additives that affect our daily lives. At present, food additive safety evaluation standards are based on the toxicity of single additives, but food additives are often used in combination and may have additive, synergistic or antagonistic actions. The current study investigated the toxicity of food additives and mechanisms of damage in HepG2 cells using High Content Analysis (HCA). We used the CCK-8 assay to determine cell viability, providing an experimental basis for determining the safety of food additives. All of the food additives tested were observed to decrease the growth of HepG2 cells in a dose-dependent manner. Sunset yellow and sodium sulfite had IC50 values of 1.06, and 0.30g/L at 24h, respectively. HCA showed that both sunset yellow and sodium sulfite had synergistic effects on cell number, membrane permeability, mitochondrial membrane potential, intracellular calcium level, oxidative stress, and high dose group DNA damage. Copyright © 2017 Elsevier Ltd. All rights reserved.

Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials.

PubMed

Ard, J; Cannon, A; Lewis, C E; Lofton, H; Vang Skjøth, T; Stevenin, B; Pi-Sunyer, X

2016-04-01

The efficacy and safety of liraglutide 3.0 mg versus placebo, as adjunct to diet and exercise, was evaluated in racial subgroups. This post hoc analysis of pooled data from five double-blind randomized, placebo-controlled trials was conducted in 5325 adults with either a body mass index (BMI) ≥27 kg/m(2) plus ≥1 comorbidity or a BMI ≥30 kg/m(2). Statistical interaction tests evaluated possible treatment effect differences between racial subgroups: white (4496, 84.4%), black/African-American (550, 10.3%), Asian (168, 3.2%) and other (111, 2.1%). Effects of liraglutide 3.0 mg on weight loss, associated metabolic effects and safety profile were generally consistent across racial subgroups. All achieved statistically significant mean weight loss at end-of-treatment with liraglutide 3.0 mg versus placebo: white 7.7% versus 2.3%, black/African-American 6.3% versus 1.4%, Asian 6.3% versus 2.5%, other 7.3% versus 0.49%. Treatment effects on weight and cardiovascular risk markers generally showed no dependence on race (interaction test p > 0.05). Adverse events were similar across racial subgroups. © 2016 John Wiley & Sons Ltd.

Program evaluation of FHWA pedestrian and bicycle safety activities.

DOT National Transportation Integrated Search

2011-03-01

"Introduction : FHWAs Office of Highway Safety (HSA) initiated a program evaluation by Booz Allen Hamilton to assess the overall effectiveness of the Agencys Pedestrian and Bicycle Safety Program. The evaluation covers pedestrian and bicycle sa...

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis.

PubMed

Manguso, Francesco; Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23-2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03-1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00-2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76-2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24-1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44-1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.